Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects (NCT NCT01473953)
NCT ID: NCT01473953
Last Updated: 2017-03-23
Results Overview
TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Day 0 and up to 21 days after treatment
Results posted on
2017-03-23
Participant Flow
The trial was conducted at one site in Evansville, Indiana, USA.
It was a Novo Nordisk business decision, and not a decision due to safety concerns, not to continue the development of liraglutide depot. Therefore cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done. So no subjects were enrolled for the outcome measure 6.
Participant milestones
| Measure |
Cohort 1a: Lira-depot 2.25 mg
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
5
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1a: Lira-depot 2.25 mg
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=6 Participants
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 Participants
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 Participants
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 Participants
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
n=8 Participants
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
30.0 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
29.8 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
39.0 years
STANDARD_DEVIATION 8.4 • n=157 Participants
|
28.5 years
STANDARD_DEVIATION 7.9 • n=390 Participants
|
32.9 years
STANDARD_DEVIATION 10.3 • n=16 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
31 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Day 0 and up to 21 days after treatmentPopulation: The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.
Outcome measures
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=6 Participants
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 Participants
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 Participants
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 Participants
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
n=8 Participants
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Serious AE
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Severe AE
|
0 events
|
0 events
|
0 events
|
1 events
|
0 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Moderate AE
|
0 events
|
0 events
|
0 events
|
9 events
|
1 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Total adverse events (AEs)
|
3 events
|
3 events
|
4 events
|
21 events
|
13 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Mild AE
|
3 events
|
3 events
|
4 events
|
11 events
|
12 events
|
|
Number of Treatment Emergent Adverse Events (TEAEs)
Fatal AE
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dosePopulation: Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.
Outcome measures
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=6 Participants
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 Participants
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 Participants
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 Participants
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
|
690 pmol/L
Geometric Coefficient of Variation 52 • Interval 52.0 to
|
2141 pmol/L
Geometric Coefficient of Variation 25 • Interval 25.0 to
|
6977 pmol/L
Geometric Coefficient of Variation 62 • Interval 62.0 to
|
40041 pmol/L
Geometric Coefficient of Variation 35 • Interval 35.0 to
|
—
|
SECONDARY outcome
Timeframe: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dosePopulation: Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.
Outcome measures
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=6 Participants
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 Participants
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 Participants
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 Participants
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
|
15.13 hours
Geometric Coefficient of Variation 92.28 • Interval 92.28 to
|
8.09 hours
Geometric Coefficient of Variation 55.78 • Interval 55.78 to
|
13.74 hours
Geometric Coefficient of Variation 22.13 • Interval 22.13 to
|
10.46 hours
Geometric Coefficient of Variation 24.62 • Interval 24.62 to
|
—
|
SECONDARY outcome
Timeframe: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dosePopulation: Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. This evaluation was not done on placebo cohort.
Outcome measures
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=5 Participants
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 Participants
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 Participants
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 Participants
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity
|
43840 pmol.h/L
Geometric Coefficient of Variation 24 • Interval 24.0 to
|
116935 pmol.h/L
Geometric Coefficient of Variation 20 • Interval 20.0 to
|
360000 pmol.h/L
Geometric Coefficient of Variation 46 • Interval 46.0 to
|
1443038 pmol.h/L
Geometric Coefficient of Variation 22 • Interval 22.0 to
|
—
|
SECONDARY outcome
Timeframe: 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dosePopulation: Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.
Outcome measures
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=5 Participants
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 Participants
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 Participants
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 Participants
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment
|
37298 pmol.h/L
Geometric Coefficient of Variation 27 • Interval 27.0 to
|
114101 pmol.h/L
Geometric Coefficient of Variation 20 • Interval 20.0 to
|
316642 pmol.h/L
Geometric Coefficient of Variation 46 • Interval 46.0 to
|
1363187 pmol.h/L
Geometric Coefficient of Variation 21 • Interval 21.0 to
|
—
|
SECONDARY outcome
Timeframe: 0 to 168 hours after dosingPopulation: Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 and Day 21Population: The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
Outcome measures
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=6 Participants
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 Participants
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 Participants
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 Participants
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
n=8 Participants
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up
Negative
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
8 participants
|
|
Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up
Positive
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Cohort 1a: Lira-depot 2.25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2a: Lira-depot 6.75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3a: Lira-depot 15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4a: Lira-depot 30 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1a: Lira-depot 2.25 mg
n=6 participants at risk
In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
|
Cohort 2a: Lira-depot 6.75 mg
n=6 participants at risk
In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
|
Cohort 3a: Lira-depot 15 mg
n=6 participants at risk
In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
|
Cohort 4a: Lira-depot 30 mg
n=5 participants at risk
In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
|
Placebo
n=8 participants at risk
In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 3 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
16.7%
1/6 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
60.0%
3/5 • Number of events 3 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
37.5%
3/8 • Number of events 4 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
16.7%
1/6 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
100.0%
5/5 • Number of events 5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
60.0%
3/5 • Number of events 3 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
16.7%
1/6 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
16.7%
1/6 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
20.0%
1/5 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
40.0%
2/5 • Number of events 2 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
General disorders
Asthenia
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
20.0%
1/5 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
16.7%
1/6 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
General disorders
Injection site vasculitis
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
16.7%
1/6 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
20.0%
1/5 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
40.0%
2/5 • Number of events 3 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
20.0%
1/5 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
12.5%
1/8 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
20.0%
1/5 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/6 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
16.7%
1/6 • Number of events 1 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/5 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
0.00%
0/8 • The adverse events were collected in a timeframe of 7 days + 14 days follow up (Day 0 and up to 21 days after treatment)
The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation 'as treated'.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER