Trial Outcomes & Findings for A Study of TAK-385 in Hormone Treatment-naïve Participants With Prostate Cancer (NCT NCT02141659)
NCT ID: NCT02141659
Last Updated: 2018-11-19
Results Overview
DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (\>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation \>60 msec postdose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
From treatment initiation until Day 28
Results posted on
2018-11-19
Participant Flow
Participants took part in the study at 7 investigative sites in Japan from 01 May 2014 to 20 April 2017.
Japanese participants with hormone treatment-naive prostate cancer were enrolled in this study to receive TAK-385 loading dose (320 or 360 milligram \[mg\]) and maintenance dose (80, 120 or 160 mg) in two parts: Part A, dose-escalation phase, cohorts 1-4 and Part B, dose-expansion phase, cohorts 1-2.
Participant milestones
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
3
|
15
|
15
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
|---|---|---|---|---|---|---|
|
Overall Study
Major Protocol Deviation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Pretreatment Event/ Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
The safety analysis set included all participants who received at least 1 dose of study drug.
Baseline characteristics by cohort
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 5.51 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
72.0 years
STANDARD_DEVIATION 5.60 • n=4 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
75.0 years
STANDARD_DEVIATION 6.08 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
71.7 years
STANDARD_DEVIATION 3.51 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
74.5 years
STANDARD_DEVIATION 4.84 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
74.4 years
STANDARD_DEVIATION 5.53 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
74.0 years
STANDARD_DEVIATION 5.00 • n=43 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
0 Participants
n=4 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
0 Participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
0 Participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
0 Participants
n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
0 Participants
n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
0 Participants
n=43 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
4 Participants
n=4 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
3 Participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
3 Participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
15 Participants
n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
15 Participants
n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
43 Participants
n=43 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
3 participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
4 participants
n=4 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
3 participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
3 participants
n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
15 participants
n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
15 participants
n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
43 participants
n=43 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Height
|
166.0 centimeter (cm)
STANDARD_DEVIATION 5.57 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
167.0 centimeter (cm)
STANDARD_DEVIATION 3.92 • n=4 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
162.3 centimeter (cm)
STANDARD_DEVIATION 3.06 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
160.3 centimeter (cm)
STANDARD_DEVIATION 4.16 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
163.4 centimeter (cm)
STANDARD_DEVIATION 3.94 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
164.7 centimeter (cm)
STANDARD_DEVIATION 5.27 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
164.1 centimeter (cm)
STANDARD_DEVIATION 4.57 • n=43 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Weight
|
63.27 kilogram (kg)
STANDARD_DEVIATION 8.361 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
64.40 kilogram (kg)
STANDARD_DEVIATION 9.542 • n=4 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
57.97 kilogram (kg)
STANDARD_DEVIATION 2.857 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
56.80 kilogram (kg)
STANDARD_DEVIATION 1.992 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
64.43 kilogram (kg)
STANDARD_DEVIATION 7.891 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
59.34 kilogram (kg)
STANDARD_DEVIATION 5.440 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
61.59 kilogram (kg)
STANDARD_DEVIATION 7.017 • n=43 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
|
Body Mass Index (BMI)
|
22.90 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.100 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
23.03 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.841 • n=4 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
22.00 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.400 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
22.17 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.498 • n=3 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
24.17 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.109 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
21.93 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.475 • n=15 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
22.90 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.694 • n=43 Participants • The safety analysis set included all participants who received at least 1 dose of study drug.
|
PRIMARY outcome
Timeframe: From treatment initiation until Day 28Population: The DLT analysis set included all participants enrolled in cohort A that meeting the following; who had taken at least 80 percent (%) of the doses of TAK-385 (23 doses) during the DLT evaluation period and for whom the DLT evaluation period observations had been completed or who had experienced DLTs during the DLT evaluation period.
DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (\>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation \>60 msec postdose.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 68)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 68)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: White Blood Cell Low
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Neutrophil Count Low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Lymphocyte Count Low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Potassium Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 68)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Body Temperature <35.6 degree Celsius
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Systolic BP >180 millimeter of Mercury (mmHg)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Diastolic BP <50 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Pulse <50 beats per minute (bpm)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 68)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters
Heart Rate <50 bpm
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters
QT Interval >=460 millisecond (msec)
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 712)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part B: Number of Participants Reporting One or More TEAE
|
15 Participants
|
15 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 712)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase \[GOT\]) High, creatine kinase (CK) (creatine phosphokinase \[CPK\]) High, prothrombin time (PT)-international normalized ratio (INR) High.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: White Blood Cell Low
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 3: White Blood Cell Low
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 3: Hemoglobin Low
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Neutrophil Count Low
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Lymphocyte Count Low
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 3: Lymphocyte Count Low
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Glucose High
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 3: Bilirubin Total High
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: AST (GOT) High
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Gamma-glutamyl Transferase (GGT) High
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: CK (CPK) High
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Potassium Low
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Corrected Calcium Low
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: PT- INR High
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 2: Triglycerides High
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities
Grade 3: Triglycerides High
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 712)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Here "BP" is blood pressure.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Body Temperature <35.6 degree Celsius
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Systolic BP >180 mmHg
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Diastolic BP >110 mmHg
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Diastolic BP <50 mmHg
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters
Pulse <50 bpm
|
2 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From treatment initiation until 40 days after last dose of study drug (Day 712)Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters
Heart Rate <50 bpm
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters
QT Interval >=460 msec
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters
QTcF Interval >=500 msec
|
2 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dosePopulation: The pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28
Day 14
|
23.53 nanogram per milliliter (ng/mL)
Standard Deviation 1.4189
|
94.40 nanogram per milliliter (ng/mL)
Standard Deviation 115.08
|
216.1 nanogram per milliliter (ng/mL)
Standard Deviation 151.78
|
65.57 nanogram per milliliter (ng/mL)
Standard Deviation 40.840
|
|
Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28
Day 1
|
191.7 nanogram per milliliter (ng/mL)
Standard Deviation 94.405
|
198.0 nanogram per milliliter (ng/mL)
Standard Deviation 62.386
|
250.0 nanogram per milliliter (ng/mL)
Standard Deviation 207.56
|
254.0 nanogram per milliliter (ng/mL)
Standard Deviation 330.58
|
|
Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28
Day 28
|
38.10 nanogram per milliliter (ng/mL)
Standard Deviation 21.743
|
34.43 nanogram per milliliter (ng/mL)
Standard Deviation 24.962
|
94.70 nanogram per milliliter (ng/mL)
Standard Deviation 114.98
|
25.56 nanogram per milliliter (ng/mL)
Standard Deviation 16.275
|
SECONDARY outcome
Timeframe: Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dosePopulation: The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28
Day 1
|
679.7 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 96.340
|
933.0 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 604.30
|
761.7 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 249.78
|
663.3 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 501.85
|
|
Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28
Day 14
|
199.0 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 49.487
|
363.8 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 291.00
|
741.7 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 385.96
|
379.0 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 199.65
|
|
Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28
Day 28
|
239.0 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 75.020
|
323.4 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 230.40
|
469.0 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 458.21
|
227.5 hour*nanogram per milliter (h*ng/mL)
Standard Deviation 138.37
|
SECONDARY outcome
Timeframe: Up to Day 35Population: The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 Participants
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 28
|
0.137 ng/mL
Standard Deviation 0.0577
|
0.200 ng/mL
Standard Deviation 0.0700
|
0.190 ng/mL
Standard Deviation 0.0693
|
0.243 ng/mL
Standard Deviation 0.0802
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Baseline
|
5.440 ng/mL
Standard Deviation 1.6829
|
6.505 ng/mL
Standard Deviation 2.6175
|
6.317 ng/mL
Standard Deviation 1.7503
|
7.853 ng/mL
Standard Deviation 1.1885
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 2
|
0.603 ng/mL
Standard Deviation 0.1457
|
0.977 ng/mL
Standard Deviation 0.5288
|
0.777 ng/mL
Standard Deviation 0.2485
|
1.477 ng/mL
Standard Deviation 1.3540
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 3
|
0.350 ng/mL
Standard Deviation 0.0917
|
0.460 ng/mL
Standard Deviation 0.1852
|
0.483 ng/mL
Standard Deviation 0.1762
|
0.623 ng/mL
Standard Deviation 0.3232
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 7
|
0.283 ng/mL
Standard Deviation 0.0764
|
0.380 ng/mL
Standard Deviation 0.2177
|
0.377 ng/mL
Standard Deviation 0.1332
|
0.337 ng/mL
Standard Deviation 0.0416
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 14
|
0.140 ng/mL
Standard Deviation 0.0173
|
0.213 ng/mL
Standard Deviation 0.1102
|
0.213 ng/mL
Standard Deviation 0.1012
|
0.203 ng/mL
Standard Deviation 0.0379
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 21
|
0.143 ng/mL
Standard Deviation 0.0635
|
0.220 ng/mL
Standard Deviation 0.1044
|
0.207 ng/mL
Standard Deviation 0.0635
|
0.207 ng/mL
Standard Deviation 0.0666
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 31
|
0.137 ng/mL
Standard Deviation 0.0416
|
0.217 ng/mL
Standard Deviation 0.1002
|
0.170 ng/mL
Standard Deviation 0.0436
|
0.210 ng/mL
Standard Deviation 0.0854
|
|
Part A: Serum Testosterone Concentrations for TAK-385
Day 35
|
0.130 ng/mL
Standard Deviation 0.0436
|
0.290 ng/mL
Standard Deviation 0.2433
|
0.153 ng/mL
Standard Deviation 0.0321
|
0.167 ng/mL
Standard Deviation 0.0473
|
SECONDARY outcome
Timeframe: Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1)Population: The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF)
|
-89.77 percent change
Standard Deviation 13.886
|
-93.91 percent change
Standard Deviation 5.161
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 49 Day 1Population: The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=14 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 1 Day 1
|
0.000 ng/mL
Standard Deviation 0.0000
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 1 Day 1: 2 hours postdose
|
72.89 ng/mL
Standard Deviation 123.81
|
88.58 ng/mL
Standard Deviation 124.65
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 1 Day 2
|
6.406 ng/mL
Standard Deviation 6.0223
|
9.854 ng/mL
Standard Deviation 7.4824
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 1 Day 4
|
4.683 ng/mL
Standard Deviation 2.7897
|
7.565 ng/mL
Standard Deviation 5.0412
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 2 Day 1
|
3.972 ng/mL
Standard Deviation 1.7426
|
8.146 ng/mL
Standard Deviation 5.3370
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 3 Day 1
|
4.123 ng/mL
Standard Deviation 2.2959
|
8.618 ng/mL
Standard Deviation 6.8455
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 5 Day 1
|
4.122 ng/mL
Standard Deviation 1.8301
|
9.105 ng/mL
Standard Deviation 6.6634
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 5 Day 1: 2 hours postdose
|
20.90 ng/mL
Standard Deviation 19.603
|
30.82 ng/mL
Standard Deviation 35.770
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 9 Day 1
|
4.076 ng/mL
Standard Deviation 2.1577
|
9.496 ng/mL
Standard Deviation 6.6435
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 13 Day 1
|
4.239 ng/mL
Standard Deviation 2.2374
|
9.820 ng/mL
Standard Deviation 7.2860
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 17 Day 1
|
4.759 ng/mL
Standard Deviation 2.9601
|
9.269 ng/mL
Standard Deviation 6.2961
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 21 Day 1
|
4.254 ng/mL
Standard Deviation 2.0265
|
11.08 ng/mL
Standard Deviation 10.873
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 25 Day 1
|
5.592 ng/mL
Standard Deviation 3.2911
|
11.95 ng/mL
Standard Deviation 11.792
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 37 Day 1
|
4.924 ng/mL
Standard Deviation 3.7682
|
11.32 ng/mL
Standard Deviation 10.759
|
—
|
—
|
|
Part B: Plasma Concentration of Unchanged TAK-385
Week 49 Day 1
|
4.683 ng/mL
Standard Deviation 3.1686
|
10.08 ng/mL
Standard Deviation 8.1482
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 97 Day 1Population: The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.
Outcome measures
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 Participants
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
|---|---|---|---|---|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 49 Day 1
|
0.228 ng/mL
Standard Deviation 0.0922
|
0.196 ng/mL
Standard Deviation 0.0849
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Baseline
|
6.367 ng/mL
Standard Deviation 1.9930
|
7.243 ng/mL
Standard Deviation 2.2424
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 1 Day 2
|
0.975 ng/mL
Standard Deviation 0.5247
|
0.867 ng/mL
Standard Deviation 0.5835
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 1 Day 4
|
0.384 ng/mL
Standard Deviation 0.0968
|
0.463 ng/mL
Standard Deviation 0.2313
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 2 Day 1
|
0.285 ng/mL
Standard Deviation 0.0741
|
0.318 ng/mL
Standard Deviation 0.1165
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 3 Day 1
|
0.207 ng/mL
Standard Deviation 0.0580
|
0.235 ng/mL
Standard Deviation 0.0925
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 5 Day 1
|
0.213 ng/mL
Standard Deviation 0.0701
|
0.190 ng/mL
Standard Deviation 0.0670
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 9 Day 1
|
0.195 ng/mL
Standard Deviation 0.0554
|
0.191 ng/mL
Standard Deviation 0.0818
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 13 Day 1
|
0.209 ng/mL
Standard Deviation 0.0746
|
0.181 ng/mL
Standard Deviation 0.0631
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 17 Day 1
|
0.217 ng/mL
Standard Deviation 0.0757
|
0.175 ng/mL
Standard Deviation 0.0548
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 21 Day 1
|
0.222 ng/mL
Standard Deviation 0.0844
|
0.179 ng/mL
Standard Deviation 0.0794
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 25 Day 1
|
0.218 ng/mL
Standard Deviation 0.0816
|
0.202 ng/mL
Standard Deviation 0.1069
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 37 Day 1
|
0.229 ng/mL
Standard Deviation 0.1046
|
0.208 ng/mL
Standard Deviation 0.1177
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 61 Day 1
|
0.204 ng/mL
Standard Deviation 0.0823
|
0.212 ng/mL
Standard Deviation 0.1111
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 73 Day 1
|
0.218 ng/mL
Standard Deviation 0.0974
|
0.203 ng/mL
Standard Deviation 0.1206
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 85 Day 1
|
0.253 ng/mL
Standard Deviation 0.0878
|
0.259 ng/mL
Standard Deviation 0.1358
|
—
|
—
|
|
Part B: Serum Testosterone Concentrations for TAK-385
Week 97 Day 1
|
0.283 ng/mL
Standard Deviation 0.1364
|
0.311 ng/mL
Standard Deviation 0.1792
|
—
|
—
|
Adverse Events
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 participants at risk
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device loosening
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Part A Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=3 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=4 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 3: TAK-385 320 mg + TAK-385 160 mg
n=3 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 160 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part A Cohort 4: TAK-385 360 mg + TAK-385 120 mg
n=3 participants at risk
TAK-385 360 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 28.
|
Part B Cohort 1: TAK-385 320 mg + TAK-385 80 mg
n=15 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 80 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
Part B Cohort 2: TAK-385 320 mg + TAK-385 120 mg
n=15 participants at risk
TAK-385 320 mg loading dose, tablet, orally, once on Day 1, followed by TAK-385 120 mg maintenance dose, tablet, orally, once daily through Days 2 to 672.
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bradycardia
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
26.7%
4/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Conjunctivitis
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
5/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
5/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hot flush
|
66.7%
2/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
40.0%
6/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
60.0%
9/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tinea manuum
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Astigmatism
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
3/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
5/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Hangover
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
3/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
3/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Bone density decreased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Occult blood
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Listless
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Scrotal mass
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • From treatment initiation until 40 days after last dose of study drug (Day 68 for Part A and Day 712 for Part B)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER