Trial Outcomes & Findings for Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure (NCT NCT03254108)
NCT ID: NCT03254108
Last Updated: 2021-07-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Results posted on
2021-07-28
Participant Flow
A total of 74 subjects were screened for this trial, 13 were screen failures, and 61 were randomly assigned to one of the treatment groups. One subject assigned to the OPC-61815 16-mg group was withdrawn due to dehydration before initiation of the trial drug administration; therefore, 60 subjects received at least 1 dosing of the trial drug.
Participant milestones
| Measure |
OPC-61815 Injection 2mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
|
OPC-61815 Injection 4mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
|
OPC-61815 Injection 8mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
|
OPC-61815 Injection 16mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
|
Tolvaptan Tablet 15mg
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
12
|
12
|
|
Overall Study
Received Treatment
|
13
|
12
|
12
|
11
|
12
|
|
Overall Study
COMPLETED
|
13
|
10
|
12
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
OPC-61815 Injection 2mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
|
OPC-61815 Injection 4mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
|
OPC-61815 Injection 8mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
|
OPC-61815 Injection 16mg
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
|
Tolvaptan Tablet 15mg
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
1
|
1
|
|
Overall Study
AST/ALT is increased to 3 times upper limit of normal or higher
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure
Baseline characteristics by cohort
| Measure |
OPC-61815 Injection 2mg
n=13 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
|
OPC-61815 Injection 4mg
n=12 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
|
OPC-61815 Injection 8mg
n=12 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
|
OPC-61815 Injection 16mg
n=11 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
|
Tolvaptan Tablet 15mg
n=12 Participants
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
73.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
74.5 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
72.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
77.9 years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
74.8 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
74.6 years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drugPopulation: Subjects treated with the IMP at least once and had at least 1 data of primary endpoint after IMP administration
Outcome measures
| Measure |
OPC-61815 Injection 2mg
n=11 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
|
OPC-61815 Injection 4mg
n=12 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
|
OPC-61815 Injection 8mg
n=12 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
|
OPC-61815 Injection 16mg
n=11 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
|
Tolvaptan Tablet 15mg
n=12 Participants
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1
|
41.4 ng/mL
Standard Deviation 11.4
|
98.6 ng/mL
Standard Deviation 43.7
|
149 ng/mL
Standard Deviation 61.7
|
282 ng/mL
Standard Deviation 96.0
|
325 ng/mL
Standard Deviation 194
|
PRIMARY outcome
Timeframe: Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drugPopulation: Subjects treated with the IMP at least once and had at least 1 data of primary endpoint after IMP administration
Outcome measures
| Measure |
OPC-61815 Injection 2mg
n=11 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
|
OPC-61815 Injection 4mg
n=12 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
|
OPC-61815 Injection 8mg
n=12 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
|
OPC-61815 Injection 16mg
n=11 Participants
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
|
Tolvaptan Tablet 15mg
n=12 Participants
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1
|
356 ng*h/mL
Standard Deviation 157
|
983 ng*h/mL
Standard Deviation 563
|
1340 ng*h/mL
Standard Deviation 522
|
2400 ng*h/mL
Standard Deviation 1030
|
2850 ng*h/mL
Standard Deviation 1580
|
Adverse Events
OPC-61815 Injection 2mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
OPC-61815 Injection 4mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
OPC-61815 Injection 8mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
OPC-61815 Injection 16mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Tolvaptan Tablet 15mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-61815 Injection 2mg
n=13 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
|
OPC-61815 Injection 4mg
n=12 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
|
OPC-61815 Injection 8mg
n=12 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
|
OPC-61815 Injection 16mg
n=11 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
|
Tolvaptan Tablet 15mg
n=12 participants at risk
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
Other adverse events
| Measure |
OPC-61815 Injection 2mg
n=13 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
|
OPC-61815 Injection 4mg
n=12 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
|
OPC-61815 Injection 8mg
n=12 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
|
OPC-61815 Injection 16mg
n=11 participants at risk
Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
|
Tolvaptan Tablet 15mg
n=12 participants at risk
Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Eye disorders
Dry eye
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
General disorders
Catheter site erythema
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
General disorders
Thirst
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Investigations
Blood potassium increased
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Investigations
Blood urea increased
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Investigations
Electrocardiogram QT prolonged
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
|
Vascular disorders
Jugular vein distension
|
7.7%
1/13 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 15 days
Subjects who received at least 1 dose of IMP were included in the safety analysis.
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Phone: +81-3-6361-7366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place