Trial Outcomes & Findings for A Safety, Tolerability, and Pharmacokinetics Study of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies (NCT NCT02412722)
NCT ID: NCT02412722
Last Updated: 2020-02-28
Results Overview
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
From Day 1, Cycle 1 through 30 days after the last dose of study drug (up to 15 months)
Results posted on
2020-02-28
Participant Flow
Participants took part in the study at 4 investigative sites in United States from 26 March 2015 to 31 May 2018.
Participants were enrolled in 3 cohorts in the study: 1)Single-Agent QD Arm, 2)Combination Arm and 3)Single-Agent QW Arm. Participants in Single-Agent QD Arm first completed pharmacokinetic (PK) run-in period, to assess the effect of dosing condition (ie, fed vs fasted) and manufacturing process (ie, milled vs unmilled API) on PK of sapanisertib.
Participant milestones
| Measure |
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
7
|
15
|
7
|
13
|
|
Overall Study
Safety Population
|
11
|
6
|
7
|
15
|
7
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
7
|
15
|
7
|
13
|
Reasons for withdrawal
| Measure |
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
3
|
0
|
3
|
|
Overall Study
Progressive Disease
|
6
|
4
|
4
|
9
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Received drug in run-in and discontinued
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason not Specified
|
3
|
0
|
2
|
1
|
2
|
6
|
Baseline Characteristics
A Safety, Tolerability, and Pharmacokinetics Study of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies
Baseline characteristics by cohort
| Measure |
Single-Agent QD Arm: Sapanisertib 3 mg
n=11 Participants
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
n=8 Participants
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
n=7 Participants
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
n=15 Participants
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
n=7 Participants
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
n=13 Participants
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 15.76 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 8.17 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 12.74 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 16.45 • n=21 Participants
|
60.5 years
STANDARD_DEVIATION 12.02 • n=10 Participants
|
60.7 years
STANDARD_DEVIATION 12.47 • n=115 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
58 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
49 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
|
Height
|
163.9 cm
STANDARD_DEVIATION 7.78 • n=5 Participants
|
168.0 cm
STANDARD_DEVIATION 8.52 • n=7 Participants
|
170.2 cm
STANDARD_DEVIATION 6.68 • n=5 Participants
|
166.0 cm
STANDARD_DEVIATION 11.43 • n=4 Participants
|
165.3 cm
STANDARD_DEVIATION 11.92 • n=21 Participants
|
164.4 cm
STANDARD_DEVIATION 5.05 • n=10 Participants
|
165.9 cm
STANDARD_DEVIATION 8.76 • n=115 Participants
|
|
Weight
|
71.2 kg
STANDARD_DEVIATION 17.02 • n=5 Participants
|
74.4 kg
STANDARD_DEVIATION 14.11 • n=7 Participants
|
87.2 kg
STANDARD_DEVIATION 35.23 • n=5 Participants
|
75.3 kg
STANDARD_DEVIATION 27.45 • n=4 Participants
|
63.3 kg
STANDARD_DEVIATION 15.55 • n=21 Participants
|
61.8 kg
STANDARD_DEVIATION 11.10 • n=10 Participants
|
71.6 kg
STANDARD_DEVIATION 21.96 • n=115 Participants
|
PRIMARY outcome
Timeframe: From Day 1, Cycle 1 through 30 days after the last dose of study drug (up to 15 months)Population: Safety population included participants who received at least 1 dose of study drug. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=19 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=19 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=17 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=11 Participants
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
n=6 Participants
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
n=7 Participants
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
n=15 Participants
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
n=7 Participants
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
n=13 Participants
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
At least one AE
|
7 Participants
|
6 Participants
|
9 Participants
|
11 Participants
|
6 Participants
|
7 Participants
|
14 Participants
|
6 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious AE
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Days 3 and 5 predose and at multiple time points (up to 24 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=19 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=17 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration of Sapanisertib Milled Active Pharmaceutical Ingredient (API) Capsules Under Fasted and Fed Conditions
|
21.6 ng/mL
Geometric Coefficient of Variation 37.4
|
36.4 ng/mL
Geometric Coefficient of Variation 50.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 3 and 5 predose and at multiple time points (up to 24 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=19 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=17 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of AUC(0-last): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of Sapanisertib Milled API Capsules Under Fasted and Fed Conditions
|
205.9 ng*hr/mL
Geometric Coefficient of Variation 59.8
|
229.2 ng*hr/mL
Geometric Coefficient of Variation 58.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 3 and 5 predose and at multiple time points (up to 24 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters. Overall number of participants analyzed is the number of participants with the data available for this outcome measure.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=13 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=13 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Sapanisertib Milled API Capsules Under Fasted and Fed Conditions
|
382.8 ng*hr/mL
Geometric Coefficient of Variation 64.7
|
369.2 ng*hr/mL
Geometric Coefficient of Variation 50.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Day 2 pre-dose and at multiple time points (up to 8 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=7 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=15 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration of Sapanisertib Milled API Capsules Under Fasted Conditions Approximately 24 Hours After Paclitaxel Infusion
|
35.2 ng/mL
Standard Deviation 22.33
|
71.4 ng/mL
Standard Deviation 29.16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Day 2 pre-dose and at multiple time points (up to 8 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=7 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=15 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration of Sapanisertib Milled API Capsules Under Fasted Conditions Approximately 24 Hours After Paclitaxel Infusion
|
2.2 hours
Interval 0.9 to 5.6
|
1.1 hours
Interval 0.5 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, Day 2 pre-dose and at multiple time points (up to 8 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=7 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=15 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-8): Area Under the Plasma Concentration Curve From Time Zero to 8 Hours Post-dose for Sapanisertib Milled API Capsules Under Fasted Conditions Approximately 24 Hours After Paclitaxel Infusion
|
144.8 ng*hr/mL
Standard Deviation 84.15
|
260.6 ng*hr/mL
Standard Deviation 89.59
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 3 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=17 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=19 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=7 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=13 Participants
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration of Sapanisertib Milled Versus Unmilled API Capsules Under Fasted Conditions
|
36.4 ng/mL
Geometric Coefficient of Variation 50.6
|
34.0 ng/mL
Geometric Coefficient of Variation 48.1
|
208.6 ng/mL
Geometric Coefficient of Variation 17.3
|
235.2 ng/mL
Geometric Coefficient of Variation 43.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 3 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=17 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=19 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=7 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=13 Participants
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of AUC(0-last): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration for Sapanisertib Milled Versus Unmilled API Capsules Under Fasted Conditions
|
229.2 hr*ng/mL
Geometric Coefficient of Variation 58.2
|
204.6 hr*ng/mL
Geometric Coefficient of Variation 57.3
|
1238.1 hr*ng/mL
Geometric Coefficient of Variation 53.3
|
1528.8 hr*ng/mL
Geometric Coefficient of Variation 43.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 3 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters. Overall number of participants analyzed is the number of participants with the data available for this outcome measure.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=13 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=13 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=7 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=13 Participants
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Sapanisertib Milled Versus Unmilled API Capsules Under Fasted Conditions
|
369.2 hr*ng/mL
Geometric Coefficient of Variation 50.0
|
400.8 hr*ng/mL
Geometric Coefficient of Variation 48.2
|
1326.2 hr*ng/mL
Geometric Coefficient of Variation 61.5
|
1636.6 hr*ng/mL
Geometric Coefficient of Variation 45.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline then every 2 cycles beginning at Cycle 3, Day 1, until disease progression, death or end of study (Up to 14 months)Population: Safety population included participants who received at least 1 dose of study drug.
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=11 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=6 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=7 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=15 Participants
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
n=7 Participants
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
n=13 Participants
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)
|
9.1 percentage of participants
|
16.7 percentage of participants
|
14.3 percentage of participants
|
20.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline then every 2 cycles beginning at Cycle 3, Day 1, until disease progression, death or end of study (Up to 14 months)Population: Data was not collected for this outcome measure.
PFS is defined as the time from the date of first study drug administration to the date of first documented PD or death due to any cause. PD was based on response evaluation criteria in solid tumors (RECIST V1.1), defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline then every 2 cycles beginning at Cycle 3, Day 1, until disease progression, death or end of study (Up to 14 months)Population: Safety population included participants who received at least 1 dose of study drug.
CBR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
PK-Run In Period Fasted (Unmilled)
n=11 Participants
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=6 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=7 Participants
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=15 Participants
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
n=7 Participants
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
n=13 Participants
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Response (CBR)
CR+PR+SD
|
63.6 percentage of participants
|
33.3 percentage of participants
|
42.9 percentage of participants
|
53.3 percentage of participants
|
42.9 percentage of participants
|
46.2 percentage of participants
|
—
|
—
|
—
|
|
Clinical Benefit Response (CBR)
CR + PR + SD (>= 6 Months)
|
36.4 percentage of participants
|
33.3 percentage of participants
|
14.3 percentage of participants
|
26.7 percentage of participants
|
0.0 percentage of participants
|
7.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Cycle 1 Day -14 to 14 monthsPopulation: Data was not collected for this outcome measure.
Changes in tumor size and volume will be determined by measurements from computed tomography (CT) and magnetic resonance imaging (MRI) scans.
Outcome measures
Outcome data not reported
Adverse Events
PK-Run In Period Fasted (Unmilled)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
PK-Run In Period Fed (Milled)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PK-Run In Period Fasted (Milled)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Single-Agent QD Arm: Sapanisertib 3 mg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Single-Agent QD Arm: Sapanisertib 4 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
Serious events: 7 serious events
Other events: 14 other events
Deaths: 1 deaths
Single-Agent QW Arm: Sapanisertib 20 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Single-Agent QW Arm: Sapanisertib 30 mg
Serious events: 7 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PK-Run In Period Fasted (Unmilled)
n=19 participants at risk
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=19 participants at risk
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=17 participants at risk
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=11 participants at risk
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
n=6 participants at risk
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
n=7 participants at risk
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
n=15 participants at risk
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
n=7 participants at risk
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
n=13 participants at risk
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Fatigue
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Clostridium test positive
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoid cystic carcinoma
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Vascular disorders
Haematoma
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
Other adverse events
| Measure |
PK-Run In Period Fasted (Unmilled)
n=19 participants at risk
Sapanisertib, 4 mg, unmilled capsules, orally, QD under fasted conditions on Day 1 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fed (Milled)
n=19 participants at risk
Sapanisertib, 4 mg, milled capsules, orally, QD, under fed conditions on Day 3 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
PK-Run In Period Fasted (Milled)
n=17 participants at risk
Sapanisertib, 4 mg, milled capsules, orally, QD under fasted conditions on Day 5 in 14-day PK Run-In Period prior to Cycle 1, Day 1.
|
Single-Agent QD Arm: Sapanisertib 3 mg
n=11 participants at risk
Following Pharmacokinetic (PK) - Run in Period, sapanisertib 3 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 9 cycles.
|
Single-Agent QD Arm: Sapanisertib 4 mg
n=6 participants at risk
Following PK Run-In Period, sapanisertib 4 mg milled capsules, orally, once, daily in a 28-day Cycle, under fasted conditions, starting from Cycle 2 for up to 13 cycles.
|
Combination Arm: Sapanisertib 4 mg + Paclitaxel 80 mg/m^2
n=7 participants at risk
Sapanisertib 4 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 12 cycles, and paclitaxel 80 mg/m\^2, intravenously (IV), on Days 1, 8, and 15 in 28-day Cycle, for up to 6 cycles.
|
Combination Arm: Sapanisertib 6 mg + Paclitaxel 80 mg/m^2
n=15 participants at risk
Sapanisertib 6 mg milled capsules, orally, once, for 3 consecutive days following each paclitaxel administration (Days 2-4, 9-11, 16-18, and 23-25) in a 28-day Cycle, under fasted conditions, for up to 9 cycles, and paclitaxel 80 mg/m\^2, IV, on Days 1, 8, and 15 in 28-day Cycle, for up to 9 cycles.
|
Single-Agent QW Arm: Sapanisertib 20 mg
n=7 participants at risk
Sapanisertib 20 mg, capsules milled API, QW in a 28-day Cycle, for up to 6 cycles.
|
Single-Agent QW Arm: Sapanisertib 30 mg
n=13 participants at risk
Sapanisertib 30 mg, capsules, milled API, QW in a 28-day Cycle, for up to 10 cycles.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
26.7%
4/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Eye disorders
Photopsia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Eye disorders
Visual impairment
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
45.5%
5/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
71.4%
5/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
40.0%
6/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
57.1%
4/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
46.2%
6/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
66.7%
4/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
71.4%
5/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
53.3%
8/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
57.1%
4/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Vomiting
|
21.1%
4/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
11.8%
2/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
27.3%
3/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
5/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
53.8%
7/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
2/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
57.1%
4/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
26.7%
4/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
27.3%
3/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
26.7%
4/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Constipation
|
10.5%
2/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Fatigue
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
54.5%
6/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
66.7%
4/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
60.0%
9/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
42.9%
3/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
61.5%
8/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Asthenia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
26.7%
4/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Chills
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Oedema
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Catheter site pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Catheter site rash
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Chest pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Facial pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Malaise
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
General disorders
Peripheral swelling
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
26.7%
4/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
2/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Weight decreased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
2/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Amylase increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood urea increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Hear rate irregular
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Lymph node palpable
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
36.4%
4/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
2/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
42.9%
3/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
53.3%
8/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
2/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
23.1%
3/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
10.5%
2/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
27.3%
3/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
42.9%
3/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Tremor
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
27.3%
3/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
2/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Psychiatric disorders
Thinking abnormal
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
18.2%
2/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
54.5%
6/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
50.0%
3/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
7.7%
1/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
36.4%
4/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
15.4%
2/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
33.3%
2/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Pain Of skin
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
28.6%
2/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
20.0%
3/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Vascular disorders
Flushing
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
13.3%
2/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Vascular disorders
Hypotension
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
6.7%
1/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
16.7%
1/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
9.1%
1/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
14.3%
1/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Transaminases increased
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
5.9%
1/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Urinary retension
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Renal and urinary disorders
Hydronephrosis
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
|
Investigations
Blood uric acid increased
|
5.3%
1/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/19 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/17 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/11 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/6 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/15 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/7 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
0.00%
0/13 • From first dose of study drug up to 30 days post last dose (Up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER