Trial Outcomes & Findings for Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects (NCT NCT05742984)
NCT ID: NCT05742984
Last Updated: 2025-05-07
Results Overview
Linaprazan area under the plasma concentration curve, from 0 to 24h post dose on Day 1 and Day 14. QD groups only.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
75 participants
Primary outcome timeframe
Day 1 and Day 14
Results posted on
2025-05-07
Participant Flow
A total of 132 subjects were screened, of which 75 subjects were randomized, including 2 subjects who did not receive any study medication. Hence 73 subjects were randomized and received at least 1 dose of linaprazan glurate. Three subjects withdrew consent and 3 subjects discontinued due to adverse AEs. A total of 69 subjects completed the study.
Participant milestones
| Measure |
25 mg Linaprazan Glurate QD
25 mg ( one 25 mg oral tablet) Linaprazan Glurate QD for 14 days
Linaprazan Glurate 25 mg: The participating subjects will receive 25 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
50 mg Linaprazan Glurate QD
50 mg (two 25 mg oral tablets) Linaprazan Glurate QD for 14 days
Linaprazan Glurate 50 mg: The participating subjects will receive 50 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
75 mg Linaprazan Glurate QD
75 mg ( three 25 mg oral tablet) Linaprazan Glurate QD for 14 days
Linaprazan Glurate 75 mg: The participating subjects will receive 75 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
25 mg Linaprazan Glurate BID
25 mg ( one 25mg oral tablet) Linaprazan Glurate BID for 14 days
Linaprazan Glurate 25 mg: The participating subjects will receive 25 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
50 mg Linaprazan Glurate BID
50 mg ( two 25 mg oral tablets) Linaprazan Glurate BID for 14 days
Linaprazan Glurate 50 mg: The participating subjects will receive 50 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
75 mg Linaprazan Glurate BID
75 mg ( three 25 mg oral tablet) Linaprazan Glurate BID for 14 days
Linaprazan Glurate 75 mg: The participating subjects will receive 75 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
13
|
12
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
25 mg Linaprazan Glurate QD
25 mg ( one 25 mg oral tablet) Linaprazan Glurate QD for 14 days
Linaprazan Glurate 25 mg: The participating subjects will receive 25 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
50 mg Linaprazan Glurate QD
50 mg (two 25 mg oral tablets) Linaprazan Glurate QD for 14 days
Linaprazan Glurate 50 mg: The participating subjects will receive 50 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
75 mg Linaprazan Glurate QD
75 mg ( three 25 mg oral tablet) Linaprazan Glurate QD for 14 days
Linaprazan Glurate 75 mg: The participating subjects will receive 75 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
25 mg Linaprazan Glurate BID
25 mg ( one 25mg oral tablet) Linaprazan Glurate BID for 14 days
Linaprazan Glurate 25 mg: The participating subjects will receive 25 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
50 mg Linaprazan Glurate BID
50 mg ( two 25 mg oral tablets) Linaprazan Glurate BID for 14 days
Linaprazan Glurate 50 mg: The participating subjects will receive 50 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
75 mg Linaprazan Glurate BID
75 mg ( three 25 mg oral tablet) Linaprazan Glurate BID for 14 days
Linaprazan Glurate 75 mg: The participating subjects will receive 75 mg doses of IMP, QD or BID for 14 days. After a drug holiday period (2, 4 or 6 days), linaprazan glurate will be given once more (QD or BID, on Day 16, 18 or 20). In total, 15 or 30 doses will be given.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects
Baseline characteristics by cohort
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=13 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=13 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
n=12 Participants
25 mg (one 25mg oral tablet) linaprazan glurate BID for 14 days
|
50 mg Linaprazan Glurate BID
n=11 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate BID for 14 days
|
75 mg Linaprazan Glurate BID
n=12 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate BID for 14 days
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.1 years
STANDARD_DEVIATION 8.26 • n=93 Participants
|
24.7 years
STANDARD_DEVIATION 8.35 • n=4 Participants
|
22.8 years
STANDARD_DEVIATION 2.45 • n=27 Participants
|
22.4 years
STANDARD_DEVIATION 1.88 • n=483 Participants
|
23.9 years
STANDARD_DEVIATION 3.48 • n=36 Participants
|
25.1 years
STANDARD_DEVIATION 8.25 • n=10 Participants
|
23.8 years
STANDARD_DEVIATION 6.05 • n=115 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
73 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
73 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
Slovenia
|
12 participants
n=93 Participants
|
13 participants
n=4 Participants
|
13 participants
n=27 Participants
|
12 participants
n=483 Participants
|
11 participants
n=36 Participants
|
12 participants
n=10 Participants
|
73 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Population: Overall # of participants analyzed does not match the participant flow figures due a discrepancy between "completers" and "evaluable" participants (protocol deviations). Figures here represent the number of evaluable subjects. NB! One participant in 50mg QD discontinued before completion of the full study, but only after the primary variables had been collected. Thus this participant's data was evaluable despite being a non-completer.
Linaprazan area under the plasma concentration curve, from 0 to 24h post dose on Day 1 and Day 14. QD groups only.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=13 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=12 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
AUC0-24h Linaprazan (QD)
AUC0-24h Day 1
|
5057 nmol/L*h
Standard Deviation 1650.6
|
8924 nmol/L*h
Standard Deviation 2281.0
|
13900 nmol/L*h
Standard Deviation 4339.5
|
—
|
—
|
—
|
|
AUC0-24h Linaprazan (QD)
AUC0-24h Day 14
|
4640 nmol/L*h
Standard Deviation 1657.4
|
8626 nmol/L*h
Standard Deviation 3571.9
|
11697 nmol/L*h
Standard Deviation 4053.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Linaprazan area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=11 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=10 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
AUC0-12, 12-24h Linaprazan (BID)
AUC0-12h Day 1
|
4081 nmol/L*h
Standard Deviation 1351.9
|
8084 nmol/L*h
Standard Deviation 1400.5
|
11814 nmol/L*h
Standard Deviation 3181.8
|
—
|
—
|
—
|
|
AUC0-12, 12-24h Linaprazan (BID)
AUC12-24h Day 1
|
3947 nmol/L*h
Standard Deviation 939.8
|
7107 nmol/L*h
Standard Deviation 1917.8
|
9532 nmol/L*h
Standard Deviation 2118.1
|
—
|
—
|
—
|
|
AUC0-12, 12-24h Linaprazan (BID)
AUC0-12h Day 14
|
4896 nmol/L*h
Standard Deviation 1367.3
|
7518 nmol/L*h
Standard Deviation 1627.0
|
11757 nmol/L*h
Standard Deviation 3058.3
|
—
|
—
|
—
|
|
AUC0-12, 12-24h Linaprazan (BID)
AUC12-24h Day 14
|
4002 nmol/L*h
Standard Deviation 1142.8
|
6334 nmol/L*h
Standard Deviation 2061.6
|
9609 nmol/L*h
Standard Deviation 2087.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and day 14Linaprazan maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=13 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=12 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
Cmax Linaprazan (QD)
Cmax day 1
|
527.5 nmol/L
Standard Deviation 184.929
|
1066.23 nmol/L
Standard Deviation 209.973
|
1594.42 nmol/L
Standard Deviation 585.525
|
—
|
—
|
—
|
|
Cmax Linaprazan (QD)
Cmax day 14
|
404.75 nmol/L
Standard Deviation 174.068
|
1002.00 nmol/L
Standard Deviation 538.574
|
1044.92 nmol/L
Standard Deviation 478.102
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and day 14Linaprazan maximum plasma concentration 0-12h, and 12-24h post dose for BID groups, at day 1 and day 14.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=11 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=10 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
Cmax Linaprazan (BID)
Cmax 0-12h day 1
|
658.42 nmol/L
Standard Deviation 212.101
|
1380.18 nmol/L
Standard Deviation 303.283
|
1942.00 nmol/L
Standard Deviation 667.280
|
—
|
—
|
—
|
|
Cmax Linaprazan (BID)
Cmax 12-24h day 1
|
520.92 nmol/L
Standard Deviation 126.378
|
997.09 nmol/L
Standard Deviation 363.660
|
1283.90 nmol/L
Standard Deviation 435.399
|
—
|
—
|
—
|
|
Cmax Linaprazan (BID)
Cmax 0-12h day 14
|
782.92 nmol/L
Standard Deviation 263.988
|
1148.64 nmol/L
Standard Deviation 415.251
|
1740.60 nmol/L
Standard Deviation 468.197
|
—
|
—
|
—
|
|
Cmax Linaprazan (BID)
Cmax 12-24h day 14
|
520.83 nmol/L
Standard Deviation 144.568
|
842.36 nmol/L
Standard Deviation 270.396
|
1285.50 nmol/L
Standard Deviation 443.703
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and day 14Linaprazan glurate area under the plasma concentration curve, from 0-24h post dose on Day 1 and Day 14. QD groups only.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=13 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=12 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
AUC0-24h Linaprazan Glurate (QD)
AUC0-24h Day 1
|
42 nmol/L*h
Standard Deviation 18.9
|
99 nmol/L*h
Standard Deviation 68.0
|
166 nmol/L*h
Standard Deviation 85.5
|
—
|
—
|
—
|
|
AUC0-24h Linaprazan Glurate (QD)
AUC0-24h Day 14
|
27 nmol/L*h
Standard Deviation 18.6
|
107 nmol/L*h
Standard Deviation 97.9
|
149 nmol/L*h
Standard Deviation 201.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 14Linaprazan glurate area under the plasma concentration curve, from 0 to 12h and 12-24h post dose on Day 1 and Day 14. BID groups only.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=11 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=10 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
AUC0-12h, 12-24h Linaprazan Glurate (BID)
AUC0-12h Day 1
|
40 nmol/L*h
Standard Deviation 15.5
|
117 nmol/L*h
Standard Deviation 65.3
|
179 nmol/L*h
Standard Deviation 87.4
|
—
|
—
|
—
|
|
AUC0-12h, 12-24h Linaprazan Glurate (BID)
AUC 12-24h Day 1
|
30 nmol/L*h
Standard Deviation 14.6
|
74 nmol/L*h
Standard Deviation 40.7
|
78 nmol/L*h
Standard Deviation 24.7
|
—
|
—
|
—
|
|
AUC0-12h, 12-24h Linaprazan Glurate (BID)
AUC0-12h Day 14
|
39 nmol/L*h
Standard Deviation 23.2
|
69 nmol/L*h
Standard Deviation 37.0
|
156 nmol/L*h
Standard Deviation 140.6
|
—
|
—
|
—
|
|
AUC0-12h, 12-24h Linaprazan Glurate (BID)
AUC 12-24h Day 14
|
28 nmol/L*h
Standard Deviation 10.2
|
68 nmol/L*h
Standard Deviation 38.1
|
114 nmol/L*h
Standard Deviation 91.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and day 14Linaprazan glurate maximum plasma concentration 0-24h post dose for QD groups, at day 1 and day 14.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=13 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=12 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
Cmax Linaprazan Glurate (QD)
Cmax Day 1
|
27.54 nmol/L
Standard Deviation 21.284
|
62.24 nmol/L
Standard Deviation 53.653
|
100.46 nmol/L
Standard Deviation 64.576
|
—
|
—
|
—
|
|
Cmax Linaprazan Glurate (QD)
Cmax Day 14
|
18.43 nmol/L
Standard Deviation 18.775
|
126.31 nmol/L
Standard Deviation 166.828
|
107.07 nmol/L
Standard Deviation 202.899
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and day 14Linaprazan glurate maximum plasma concentration 0-12h and 12-24h post dose for BID groups, at day 1 and day 14.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=11 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=10 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
Cmax Linaprazan Glurate (BID)
Cmax0-12h Day 1
|
32.52 nmol/L
Standard Deviation 19.704
|
101.26 nmol/L
Standard Deviation 49.177
|
148.19 nmol/L
Standard Deviation 80.799
|
—
|
—
|
—
|
|
Cmax Linaprazan Glurate (BID)
Cmax 12-24h Day 1
|
14.69 nmol/L
Standard Deviation 10.290
|
46.60 nmol/L
Standard Deviation 40.041
|
40.41 nmol/L
Standard Deviation 32.422
|
—
|
—
|
—
|
|
Cmax Linaprazan Glurate (BID)
Cmax0-12h Day 14
|
47.59 nmol/L
Standard Deviation 46.275
|
61.09 nmol/L
Standard Deviation 43.234
|
151.73 nmol/L
Standard Deviation 145.527
|
—
|
—
|
—
|
|
Cmax Linaprazan Glurate (BID)
Cmax 12-24h Day 14
|
22.29 nmol/L
Standard Deviation 13.414
|
41.51 nmol/L
Standard Deviation 38.110
|
94.42 nmol/L
Standard Deviation 140.218
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and day 14Population: PK/PD analysis set (PK/PDAS), a subset of the PK-analysis set, included all pH measurements which were evaluable. 4 subjects were excluded from the PK-analysis set, and thereby also from the PK/PDAS subset, due to study drug incompliance. Another 5 subjects were excluded entirely from the PK/PDAS due to presence of H. pylori (exclusion criteria - could have an impact on acid suppression sensitivity). In total 67 individuals provided at least 1 evaluable pH curve.
Percentage of time gastric pH \>4 at Days 1 and 14 over a 24-hour monitoring period following linaprazan glurate administration. Intragastric pH was measured every second with an intragastric probe. The measurements were compressed into 10-minute median intervalls before calculating the % of time with intragastric \>pH 4 (HTR). The HTR is presented with descriptive statistics, by dosing group.
Outcome measures
| Measure |
25 mg Linaprazan Glurate QD
n=12 Participants
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=12 Participants
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=13 Participants
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
n=9 Participants
The subjects will received 25 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
50 mg Linaprazan Glurate BID
n=11 Participants
The subjects will received 50 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
75 mg Linaprazan Glurate BID
n=10 Participants
The subjects will received 75 mg dose twice daily, in the morning and in the evening for 14 days. Subjects were fasted for ≥10 hours overnight before dosing on Day 1 and day 14, until 30 minutes post-dose. During fasting, tap water, but no other drinks, were allowed as desired, except for 1 hour before and 30 minutes after dosing.
The second daily dose was administered 30 minutes after the evening meal, i.e. in a non-fasted condition. The subjects followed a standardized food intake schedule.
|
|---|---|---|---|---|---|---|
|
Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR)
HTR (%) pH >4 day 1
|
48 % of time
Standard Deviation 23.23
|
64.6 % of time
Standard Deviation 13.33
|
68.1 % of time
Standard Deviation 23.48
|
76.0 % of time
Standard Deviation 13.52
|
87.4 % of time
Standard Deviation 8.62
|
94.5 % of time
Standard Deviation 4.18
|
|
Percentage of Time Gastric pH >4 Over a 24-hour Monitoring Period (Holding Time Ratio, HTR)
HTR (%) pH >4 day 14
|
48.5 % of time
Standard Deviation 30.62
|
63.9 % of time
Standard Deviation 20.09
|
87.2 % of time
Standard Deviation 11.44
|
76.9 % of time
Standard Deviation 20.13
|
95.7 % of time
Standard Deviation 5.55
|
99.0 % of time
Standard Deviation 1.54
|
Adverse Events
25 mg Linaprazan Glurate QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 mg Linaprazan Glurate QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
75 mg Linaprazan Glurate QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
25 mg Linaprazan Glurate BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
50 mg Linaprazan Glurate BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
75 mg Linaprazan Glurate BID
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
25 mg Linaprazan Glurate QD
n=12 participants at risk
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=13 participants at risk
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=13 participants at risk
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
n=12 participants at risk
25 mg (one 25mg oral tablet) linaprazan glurate BID for 14 days
|
50 mg Linaprazan Glurate BID
n=11 participants at risk
50 mg ( two 25 mg oral tablets) linaprazan glurate BID for 14 days
|
75 mg Linaprazan Glurate BID
n=12 participants at risk
75 mg (three 25 mg oral tablets) linaprazan glurate BID for 14 days
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Commotio cerebri
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
Other adverse events
| Measure |
25 mg Linaprazan Glurate QD
n=12 participants at risk
25 mg (one 25 mg oral tablet) linaprazan glurate QD for 14 days
|
50 mg Linaprazan Glurate QD
n=13 participants at risk
50 mg (two 25 mg oral tablets) linaprazan glurate QD for 14 days
|
75 mg Linaprazan Glurate QD
n=13 participants at risk
75 mg (three 25 mg oral tablets) linaprazan glurate QD for 14 days
|
25 mg Linaprazan Glurate BID
n=12 participants at risk
25 mg (one 25mg oral tablet) linaprazan glurate BID for 14 days
|
50 mg Linaprazan Glurate BID
n=11 participants at risk
50 mg ( two 25 mg oral tablets) linaprazan glurate BID for 14 days
|
75 mg Linaprazan Glurate BID
n=12 participants at risk
75 mg (three 25 mg oral tablets) linaprazan glurate BID for 14 days
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Number of events 6 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
23.1%
3/13 • Number of events 5 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
25.0%
3/12 • Number of events 3 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
27.3%
3/11 • Number of events 3 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
25.0%
3/12 • Number of events 5 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
General disorders
fatigue
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
9.1%
1/11 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
General disorders
Pyrexia
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Infections and infestations
Cystitis
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
9.1%
1/11 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Infections and infestations
Urinary Tract infections
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
9.1%
1/11 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Reproductive system and breast disorders
menstrual disorder
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
|
8.3%
1/12 • Number of events 2 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
9.1%
1/11 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
9.1%
1/11 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Renal and urinary disorders
Post streptoccocal glumerulonephritis
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Renal and urinary disorders
proteinuria
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Injury, poisoning and procedural complications
concussion
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Injury, poisoning and procedural complications
Facial Bones fracture
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
7.7%
1/13 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Surgical and medical procedures
arterial puncture
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/13 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/12 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
0.00%
0/11 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
8.3%
1/12 • Number of events 1 • (S)AE collection was performed on all dosed subjects, in the timeframe between first dose and until safety follow-up 7 +/-2 days after last dose, totalling ca 23-30 days of safety data collection. There was an exception made in the collection timeframe for the SAE, which occurred approximately 2 hours prior to first dose, i.e. outside the actual AE collection time frame as defined by the protocol, but since the event was deemed study procedure related it was reported as an SAE nevertheless.
AEs were coded using MedDRA® Version 25.0. Verbatim terms were coded to lower-level terms within the primary SOC. All AEs reported are MedDRA PTs unless stated otherwise. During the study, the iSRC had 4 meetings to oversee the safety of each subject and all aggregate safety data was reviewed at each meeting. Number of participants in the All cause mortality and SAE fields below relate to all dosed participants (safety analysis set).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place