Trial Outcomes & Findings for Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042) (NCT NCT03519867)
NCT ID: NCT03519867
Last Updated: 2019-01-31
Results Overview
The mean time from the start of MK-8616 administration to recovery T4/T1 ratio of 0.9 was determined. Less time indicates faster recovery from NMB. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 90 minutes
Results posted on
2019-01-31
Participant Flow
Adult participants of American Society of Anesthesiologists (ASA) Class 1-3 who were scheduled for surgery were recruited at 4 study sites in the US.
Participant milestones
| Measure |
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced neuromuscular blockade (NMB) reached 1 to 2 PTCs.
|
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
4
|
5
|
5
|
4
|
5
|
4
|
4
|
|
Overall Study
Treated
|
5
|
6
|
5
|
3
|
5
|
4
|
4
|
4
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
5
|
3
|
5
|
2
|
3
|
4
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
1
|
0
|
3
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced neuromuscular blockade (NMB) reached 1 to 2 PTCs.
|
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Admin. of relaxant other than Zemuron®
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Admin. of other reversal agent
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Reason not provided
|
1
|
1
|
1
|
1
|
0
|
1
|
0
|
1
|
1
|
0
|
Baseline Characteristics
All treated participants.
Baseline characteristics by cohort
| Measure |
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
n=5 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
n=6 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
n=5 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
n=3 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
n=5 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
n=3 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48 Years
STANDARD_DEVIATION 12 • n=93 Participants • All treated participants.
|
49 Years
STANDARD_DEVIATION 10 • n=4 Participants • All treated participants.
|
52 Years
STANDARD_DEVIATION 11 • n=27 Participants • All treated participants.
|
58 Years
STANDARD_DEVIATION 20 • n=483 Participants • All treated participants.
|
53 Years
STANDARD_DEVIATION 14 • n=36 Participants • All treated participants.
|
58 Years
STANDARD_DEVIATION 11 • n=10 Participants • All treated participants.
|
47 Years
STANDARD_DEVIATION 12 • n=115 Participants • All treated participants.
|
51 Years
STANDARD_DEVIATION 4 • n=40 Participants • All treated participants.
|
48 Years
STANDARD_DEVIATION 17 • n=8 Participants • All treated participants.
|
50 Years
STANDARD_DEVIATION 10 • n=62 Participants • All treated participants.
|
51 Years
STANDARD_DEVIATION 11 • n=95 Participants • All treated participants.
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants • All treated participants.
|
3 Participants
n=4 Participants • All treated participants.
|
2 Participants
n=27 Participants • All treated participants.
|
1 Participants
n=483 Participants • All treated participants.
|
3 Participants
n=36 Participants • All treated participants.
|
2 Participants
n=10 Participants • All treated participants.
|
2 Participants
n=115 Participants • All treated participants.
|
2 Participants
n=40 Participants • All treated participants.
|
1 Participants
n=8 Participants • All treated participants.
|
3 Participants
n=62 Participants • All treated participants.
|
21 Participants
n=95 Participants • All treated participants.
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants • All treated participants.
|
3 Participants
n=4 Participants • All treated participants.
|
3 Participants
n=27 Participants • All treated participants.
|
2 Participants
n=483 Participants • All treated participants.
|
2 Participants
n=36 Participants • All treated participants.
|
2 Participants
n=10 Participants • All treated participants.
|
2 Participants
n=115 Participants • All treated participants.
|
2 Participants
n=40 Participants • All treated participants.
|
2 Participants
n=8 Participants • All treated participants.
|
1 Participants
n=62 Participants • All treated participants.
|
22 Participants
n=95 Participants • All treated participants.
|
PRIMARY outcome
Timeframe: Up to 90 minutesPopulation: All randomized participants who received ≥1 dose of study drug, had ≥1 post baseline efficacy measurement, and did not have any important protocol violations are included.
The mean time from the start of MK-8616 administration to recovery T4/T1 ratio of 0.9 was determined. Less time indicates faster recovery from NMB. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Outcome measures
| Measure |
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
n=3 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
n=2 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
n=5 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
n=2 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
n=1 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
n=3 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
n=3 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
n=2 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9
|
44.18 Minutes
Standard Deviation 34.63
|
19.08 Minutes
Standard Deviation 19.98
|
5.38 Minutes
Standard Deviation 5.57
|
3.32 Minutes
Standard Deviation 1.63
|
1.53 Minutes
Standard Deviation 0.60
|
20.57 Minutes
Standard Deviation 0
|
11.52 Minutes
Standard Deviation 11.63
|
4.33 Minutes
Standard Deviation 0.52
|
1.92 Minutes
Standard Deviation 0.65
|
0.98 Minutes
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Up to 7 days following MK-8616 administrationPopulation: All participants who received a dose of study treatment are included.
The percentage of participants experiencing ≥1 AEs was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
n=5 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
n=6 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
n=5 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
n=3 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
n=5 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
n=3 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
n=4 Participants
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Experiencing ≥1 Adverse Events (AEs)
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
60.0 Percentage of Participants
|
66.7 Percentage of Participants
|
80.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
66.7 Percentage of Participants
|
50.0 Percentage of Participants
|
Adverse Events
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
n=5 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
n=6 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
n=5 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
n=3 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
n=5 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
n=3 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Postoperative fever
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
Other adverse events
| Measure |
1) Zemuron® 0.6 mg/kg + MK-8616 0.5 mg/kg
n=5 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
2) Zemuron® 0.6 mg/kg + MK-8616 1.0 mg/kg
n=6 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
3) Zemuron® 0.6 mg/kg + MK-8616 2.0 mg/kg
n=5 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
4) Zemuron® 0.6 mg/kg + MK-8616 4.0 mg/kg
n=3 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
5) Zemuron® 0.6 mg/kg + MK-8616 8.0 mg/kg
n=5 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 0.6 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
6) Zemuron® 1.2 mg/kg + MK-8616 0.5 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 0.5 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
7) Zemuron® 1.2 mg/kg + MK-8616 1.0 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 1.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
8) Zemuron® 1.2 mg/kg + MK-8616 2.0 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 2.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
9) Zemuron® 1.2 mg/kg + MK-8616 4.0 mg/kg
n=3 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 4.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
10) Zemuron® 1.2 mg/kg + MK-8616 8.0 mg/kg
n=4 participants at risk
Participants (ASA Class 1 to 3) received an iv bolus of Zemuron® 1.2 mg/kg followed by MK-8616 8.0 mg/kg iv during a single study session. MK-8616 was administered once Zemuron®-induced NMB reached 1 to 2 PTCs.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Nervous system disorders
Neuromuscular blockade
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Cardiac disorders
Bradycardia
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
50.0%
3/6 • Number of events 4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
40.0%
2/5 • Number of events 3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
50.0%
2/4 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
75.0%
3/4 • Number of events 3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
66.7%
2/3 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
66.7%
2/3 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
General disorders
Chills
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
2/6 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Injury, poisoning and procedural complications
Post procedural nausea
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
40.0%
2/5 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
2/6 • Number of events 3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
40.0%
2/5 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
60.0%
3/5 • Number of events 3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
50.0%
2/4 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
50.0%
2/4 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
50.0%
2/4 • Number of events 3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
50.0%
2/4 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Injury, poisoning and procedural complications
Post procedural vomiting
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Beta 2 microglobulin increased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
40.0%
2/5 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Beta-N-acetyl-D-glucosaminidase increased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Blood glucose increased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
Protein total decreased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
16.7%
1/6 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Investigations
White blood cell count increased
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Nervous system disorders
Stupor
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Reproductive system and breast disorders
Genital burning sensation
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
20.0%
1/5 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
2/6 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
33.3%
1/3 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/6 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/5 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
40.0%
2/5 • Number of events 2 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
25.0%
1/4 • Number of events 1 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/3 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
0.00%
0/4 • Up to 7 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. All participants who received a dose of study treatment are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Organon recognizes the right of the investigator(s) to publish, but all publications must be based on data validated by Organon. Any such scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to Organon, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER