Trial Outcomes & Findings for BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA) (NCT NCT04044001)
NCT ID: NCT04044001
Last Updated: 2026-08-31
Results Overview
Safety and tolerability of BTZ-043 was assessed by evaluation of Adverse Events (AEs) during treatment- and follow-up phase (Clinical observations, Vital signs, Serum chemistry, hematology and coagulation parameters with baseline measurements. Electrocardiography (ECG), including heart rate, PR interval, QRS, QT interval, QTcF; change of QTcF from baseline; morphological abnormalities).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Day 1 to Day 22
Results posted on
2026-08-31
Participant Flow
Patients were recruited from the local TB clinics, informed and consented. With the signature of the ICF, the participants were subject to screening (up to 8 days). If participant proved to be eligible, participant was allocated (stage1) or randomized (stage 2) to treatment. One participant in stage 2 was randomized but experienced an SAE before the first administration of study medication, was withdrawn from the study and replaced. This led to enrolment of 78 p. but ony 77 were started on IMP
212 participants were consented and screened for eligibility. Out of these, 78 participants were eligible and randomized to treatment, those were considered to be "enrolled".
Participant milestones
| Measure |
Stage 1 - Cohort 3 (BTZ 750)
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 1 (BTZ 250)
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
0
|
16
|
13
|
15
|
9
|
|
Overall Study
COMPLETED
|
3
|
1
|
3
|
3
|
3
|
3
|
3
|
0
|
15
|
11
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Stage 1 - Cohort 3 (BTZ 750)
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 1 (BTZ 250)
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
2
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Covid19 Infection
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
Baseline characteristics by cohort
| Measure |
Stage 1 - Cohort 1 (BTZ 250)
n=3 Participants
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
n=3 Participants
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 3 (BTZ 750)
n=3 Participants
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
n=3 Participants
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
n=3 Participants
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
n=3 Participants
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
n=6 Participants
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
n=16 Participants
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
n=14 Participants
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
n=15 Participants
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
n=9 Participants
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.7 years
STANDARD_DEVIATION 3.06 • n=14 Participants
|
45.7 years
STANDARD_DEVIATION 16.3 • n=36 Participants
|
36.7 years
STANDARD_DEVIATION 14.4 • n=324 Participants
|
27.7 years
STANDARD_DEVIATION 12.4 • n=49 Participants
|
27.7 years
STANDARD_DEVIATION 9.09 • n=573 Participants
|
26.3 years
STANDARD_DEVIATION 8.39 • n=9 Participants
|
28.2 years
STANDARD_DEVIATION 6.31 • n=8 Participants
|
—
|
30.5 years
STANDARD_DEVIATION 11.5 • n=18 Participants
|
31.7 years
STANDARD_DEVIATION 10.1 • n=19 Participants
|
30.2 years
STANDARD_DEVIATION 11.3 • n=31 Participants
|
27.2 years
STANDARD_DEVIATION 8.97 • n=15 Participants
|
30.4 years
STANDARD_DEVIATION 10.6 • n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=18 Participants
|
5 Participants
n=19 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=15 Participants
|
12 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=573 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=18 Participants
|
9 Participants
n=19 Participants
|
14 Participants
n=31 Participants
|
9 Participants
n=15 Participants
|
66 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
2 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
1 Participants
n=9 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=18 Participants
|
9 Participants
n=19 Participants
|
10 Participants
n=31 Participants
|
7 Participants
n=15 Participants
|
51 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=573 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=18 Participants
|
5 Participants
n=19 Participants
|
5 Participants
n=31 Participants
|
2 Participants
n=15 Participants
|
26 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=573 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
3 Participants
n=49 Participants
|
3 Participants
n=573 Participants
|
3 Participants
n=9 Participants
|
6 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=18 Participants
|
14 Participants
n=19 Participants
|
15 Participants
n=31 Participants
|
9 Participants
n=15 Participants
|
78 Participants
n=15 Participants
|
|
Region of Enrollment
South Africa
|
3 participants
n=14 Participants
|
3 participants
n=36 Participants
|
3 participants
n=324 Participants
|
3 participants
n=49 Participants
|
3 participants
n=573 Participants
|
3 participants
n=9 Participants
|
6 participants
n=8 Participants
|
—
|
16 participants
n=18 Participants
|
14 participants
n=19 Participants
|
15 participants
n=31 Participants
|
9 participants
n=15 Participants
|
78 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 22Population: Safety Analysis population consisted of all participants who recieves at least one dose of IMP
Safety and tolerability of BTZ-043 was assessed by evaluation of Adverse Events (AEs) during treatment- and follow-up phase (Clinical observations, Vital signs, Serum chemistry, hematology and coagulation parameters with baseline measurements. Electrocardiography (ECG), including heart rate, PR interval, QRS, QT interval, QTcF; change of QTcF from baseline; morphological abnormalities).
Outcome measures
| Measure |
Stage 1 - Cohort 1 (BTZ 250)
n=3 Participants
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
n=3 Participants
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 3 (BTZ 750)
n=3 Participants
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
n=3 Participants
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
n=3 Participants
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
n=3 Participants
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
n=3 Participants
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
n=16 Participants
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
n=14 Participants
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
n=15 Participants
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
n=9 Participants
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of BTZ-043
|
3 Adverse Event
|
17 Adverse Event
|
3 Adverse Event
|
4 Adverse Event
|
15 Adverse Event
|
10 Adverse Event
|
14 Adverse Event
|
—
|
35 Adverse Event
|
17 Adverse Event
|
21 Adverse Event
|
9 Adverse Event
|
SECONDARY outcome
Timeframe: Day -1 to Day 14. Change from Day -1 to Day 2, Day 2 - Day 14 and Day -1 to Day 14 have been assessed.Population: Day -1 data of all participants were analyzed. Data for Day 2 and Day 14 data was not available for all participants, as some did not complete the study. Data from all available data points were analyzed.
Liquid culture is inoculated with overnight sputum of the participants. Upon growth of Mycobacteria, the color of the medium is changing due to changes in pH. This is measured photometric and the time of the change in color is recorded. The more bactera are inoculated, the quicker the change ind color and the time to positivity. Overnight sputum is collected on Day -1, Day 0, Day 2, Day 3, Day 4, Day 6, Day 8, Day 11 and Day 14 to be able to follow the decrease in bacterial load over time.
Outcome measures
| Measure |
Stage 1 - Cohort 1 (BTZ 250)
n=3 Participants
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
n=3 Participants
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 3 (BTZ 750)
n=3 Participants
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
n=3 Participants
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
n=3 Participants
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
n=3 Participants
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
n=6 Participants
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
n=16 Participants
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
n=14 Participants
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
n=15 Participants
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
n=9 Participants
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Bactericidal Activity Endpoint - MGIT Time to Positivity (log10 (h))
|
0.09 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.10
|
0.22 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.07
|
0.27 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.17
|
0.24 log(10) TTP (hrs) day 14 ch.f.baseline
Only one participant in this cohort completed day 14
|
0.18 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.16
|
0.37 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.16
|
0.25 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.09
|
—
|
0.17 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.12
|
0.25 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.08
|
0.20 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.14
|
0.42 log(10) TTP (hrs) day 14 ch.f.baseline
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Day -1 to Day 14. Change from Day -1 to Day 2, Day 2 - Day 14 and Day -1 to Day 14 have been assessed.Population: Day -1 data of all participants were analyzed. Data for Day 2 and Day 14 data was not available for all participants, as some did not complete the study. Data from all available data points were analyzed.
Overnight sputum was plated on solid medium. Decrease in log 10 CFU (No. of colony forming untis) over time was assessed. Overnight sputum is collected on Day -1, Day 0, Day 2, Day 3, Day 4, Day 6, Day 8, Day 11 and Day 14 to be able to follow the decrease in bacterial load over time.
Outcome measures
| Measure |
Stage 1 - Cohort 1 (BTZ 250)
n=3 Participants
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
n=3 Participants
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 3 (BTZ 750)
n=3 Participants
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
n=3 Participants
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
n=3 Participants
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
n=3 Participants
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
n=6 Participants
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
n=16 Participants
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
n=14 Participants
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
n=15 Participants
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
n=9 Participants
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Bactericidal Activity Endpoint - CFU
|
-0.42 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 0.76
|
-1.34 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 0.27
|
-1.29 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 0.52
|
-1.08 log(10)CFU/mL day 14 ch.f.baseline
only one participant completed day 14 in this cohort
|
-1.63 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 0.63
|
-2.22 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 1.18
|
-0.96 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 1.24
|
—
|
-2.09 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 1.27
|
-1.78 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 0.85
|
-1.48 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 1.42
|
-2.66 log(10)CFU/mL day 14 ch.f.baseline
Standard Deviation 0.91
|
Adverse Events
Stage 1 - Cohort 1 (BTZ 250)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 - Cohort 2 (BTZ 500)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 - Cohort 3 (BTZ 750)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Stage 1 - Cohort 4 (BTZ 1000)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Stage 1 - Cohort 5 (BTZ 1250)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 - Cohort 6 (BTZ 1500)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 - Cohort 7 (BTZ 1750)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 1 - Cohort 8 (BTZ 2000)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2 - Arm 1 (BTZ High)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Stage 2 - Arm 2 (BTZ Medium)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 1 deaths
Stage 2 - Arm 3 (BTZ Low)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Stage 2 - Arm 4 (Control)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 - Cohort 1 (BTZ 250)
n=3 participants at risk
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
n=3 participants at risk
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 3 (BTZ 750)
n=3 participants at risk
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
n=3 participants at risk
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
n=3 participants at risk
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
n=3 participants at risk
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
n=6 participants at risk
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
n=16 participants at risk
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
n=14 participants at risk
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
n=15 participants at risk
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
n=9 participants at risk
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
Other adverse events
| Measure |
Stage 1 - Cohort 1 (BTZ 250)
n=3 participants at risk
Patients will receive 1 tablet of BTZ-043 orally once daily, containing 250mg BTZ-043 from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 2 (BTZ 500)
n=3 participants at risk
Patients will receive 2 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 3 (BTZ 750)
n=3 participants at risk
Patients will receive 3 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 4 (BTZ 1000)
n=3 participants at risk
Patients will receive 4 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1000 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 5 (BTZ 1250)
n=3 participants at risk
Patients will receive 5 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1250 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 6 (BTZ 1500)
n=3 participants at risk
Patients will receive 6 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1500 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 7 (BTZ 1750)
n=6 participants at risk
Patients will receive 7 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (1750 mg in total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 1 - Cohort 8 (BTZ 2000)
Patients will receive 8 tablets of BTZ-043 orally once daily, each containing 250mg BTZ-043 (2000 total) from Day 1 through to Day 14
BTZ-043: BTZ-043 (250mg per tablet)
|
Stage 2 - Arm 1 (BTZ High)
n=16 participants at risk
Patients will receive a higher dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 2 (BTZ Medium)
n=14 participants at risk
Patients will receive a medium dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 3 (BTZ Low)
n=15 participants at risk
Patients will receive a lower dose of BTZ-043, that has proven to be safe in stage 1 orally once daily from Day 1 through to Day 14. The dose of BTZ-043 will be determined after review of safety data from stage 1.
BTZ-043: BTZ-043 (250mg per tablet)
Probe Drug Cocktail: A probe drug cocktail will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally. The probe drug cocktail consists of
* Caffeine: 1 tablet à 150mg
* Tolbutamide: 1/4 tablet à 500mg
* Dextromethorphan: 10 ml syrup à 15mg/5ml
* Midazolam:2 ml solution à 5mg/5ml
* Digoxin: 2 tablets à 0.25mg
Dolutegravir 50mg Tab: 1 tablet à 50mg Dolutegravir will be given to randomly selected patients after inclusion on Day 1 and on Day 14 once orally.
|
Stage 2 - Arm 4 (Control)
n=9 participants at risk
Patients will receive a standard dose of Rifafour e-275® orally once daily according to body weight from Day 1 through to Day 14. Each tablet of Rifafour e-275® contains 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide and 275mg ethambutol.
The daily doses will be given to fasting patients, in accordance with South African Guidelines for treatment of TB. The total number of tablets will be based on the body weight at screening:
* participants weighing 38 - 54 kg: 3 tablets
* participants weighing 55 - 70 kg: 4 tablets
* participants weighing \>70 kg: 5 tablets
Rifafour e-275®: Rifafour e-275® (150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, 275 mg ethambutol per tablet)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctiva Irritation
|
66.7%
2/3 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
66.7%
2/3 • Number of events 3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
31.2%
5/16 • Number of events 5 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
2/6 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
Alaninaminotransferase increased
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
13.3%
2/15 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
Liver function test increased
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
66.7%
2/3 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
100.0%
3/3 • Number of events 4 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Oral mucosal discoloration
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
66.7%
2/3 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
22.2%
2/9 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
12.5%
2/16 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Refraction disorder
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
12.5%
2/16 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
66.7%
2/3 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
33.3%
1/3 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
16.7%
1/6 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
14.3%
2/14 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
14.3%
2/14 • Number of events 3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
13.3%
2/15 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Haemmorrhoids
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
18.8%
3/16 • Number of events 4 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
35.7%
5/14 • Number of events 5 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
13.3%
2/15 • Number of events 2 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
General disorders
Pain
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
7.1%
1/14 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Eye disorders
Pupil fixed
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.2%
1/16 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
6.7%
1/15 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/9 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/3 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/6 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
—
0/0 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/16 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/14 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
0.00%
0/15 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
11.1%
1/9 • Number of events 1 • From the beginning of screening (day -8) to the first administration of study drug (stage 1: Day 1) or probe drug administration (stage 2: Day 0), all symptoms etc. have been recorded as medical history. Adverse events were recorded from the first administration of study drug (stage 1) or probe drug (stage 2) until the follow-up visit on Day 22.
One AE was still under investigation on Day 22, it was followed until resolution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to first publish the results of the Trial. For this reason, prior to said publication, Trial Site or Principal Investigator are not entitled to produce their own publication or public presentation based on the data collected locally. After the release of the primary multi-centre publication, Trial Site or Principal Investigator may publish their data. Condition: Sponsor receives copy of the manuscript (45 day) to comment.
- Publication restrictions are in place
Restriction type: OTHER