Trial Outcomes & Findings for A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2) (NCT NCT01684202)
NCT ID: NCT01684202
Last Updated: 2021-03-18
Results Overview
Body weight was measured in 100-g units before breakfast and after subjects had urinated at least once, taking care to minimize fluctuations due to defecation or clothing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Baseline, at the final IMP administration (shortest:7days longest:12days)
Results posted on
2021-03-18
Participant Flow
Participant milestones
| Measure |
OPC-41061 3.75 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
OPC-41061 7.5 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
OPC-41061 15 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
OPC-41061 30 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
|---|---|---|---|---|
|
Dose-escalation Period
STARTED
|
15
|
8
|
9
|
11
|
|
Dose-escalation Period
COMPLETED
|
14
|
7
|
9
|
11
|
|
Dose-escalation Period
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Maintenance Period
STARTED
|
14
|
7
|
9
|
11
|
|
Maintenance Period
COMPLETED
|
13
|
4
|
8
|
10
|
|
Maintenance Period
NOT COMPLETED
|
1
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
OPC-41061 3.75 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
OPC-41061 7.5 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
OPC-41061 15 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
OPC-41061 30 mg
Orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days, first in a dose-escalation manner until daily urine volume increased by 500 mL or more from that at the end of the pretreatment observation period, and then for 6 consecutive days at the fixed dose at which that increase in daily urine volume was achieved. Each Arm/Group Title indicated the final dose.
|
|---|---|---|---|---|
|
Dose-escalation Period
Adverse Event
|
0
|
1
|
0
|
0
|
|
Dose-escalation Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
1
|
1
|
1
|
1
|
|
Maintenance Period
Physician Decision
|
0
|
1
|
0
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Multicenter, Open-label, Dose-finding Trial of OPC-41061 to Investigate Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety in Patients With Carcinomatous Edema (Phase 2)
Baseline characteristics by cohort
| Measure |
OPC-41061 3.75 mg
n=13 Participants
Orally administered at 3.75 mg once daily in maintenance period.
|
OPC-41061 7.5 mg
n=7 Participants
Orally administered at 7.5 mg once daily in maintenance period.
|
OPC-41061 15 mg
n=9 Participants
Orally administered at 15 mg once daily in maintenance period.
|
OPC-41061 30 mg
n=11 Participants
Orally administered at 30 mg once daily in maintenance period.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
65.3 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, at the final IMP administration (shortest:7days longest:12days)Population: Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.
Body weight was measured in 100-g units before breakfast and after subjects had urinated at least once, taking care to minimize fluctuations due to defecation or clothing.
Outcome measures
| Measure |
OPC-41061 3.75 mg
n=13 Participants
Orally administered at 3.75 mg once daily in maintenance period.
|
OPC-41061 7.5 mg
n=7 Participants
Orally administered at 7.5 mg once daily in maintenance period.
|
OPC-41061 15 mg
n=9 Participants
Orally administered at 15 mg once daily in maintenance period.
|
OPC-41061 30 mg
n=11 Participants
Orally administered at 30 mg once daily in maintenance period.
|
|---|---|---|---|---|
|
Change in Body Weight From Baseline at Final IMP Administration
|
-0.69 Kg
Standard Deviation 2.51
|
-0.34 Kg
Standard Deviation 1.99
|
-1.13 Kg
Standard Deviation 1.62
|
0.70 Kg
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: Baseline, at the final IMP administration (shortest:7days longest:12days)Population: Full analysis set: all subjects who had been administered the IMP at least once and from whom data for efficacy endpoints were obtained after the start of IMP administration.
Outcome measures
| Measure |
OPC-41061 3.75 mg
n=11 Participants
Orally administered at 3.75 mg once daily in maintenance period.
|
OPC-41061 7.5 mg
n=4 Participants
Orally administered at 7.5 mg once daily in maintenance period.
|
OPC-41061 15 mg
n=8 Participants
Orally administered at 15 mg once daily in maintenance period.
|
OPC-41061 30 mg
n=10 Participants
Orally administered at 30 mg once daily in maintenance period.
|
|---|---|---|---|---|
|
Change in Ascites Volume From Baseline Measured by Computer Tomography (CT) at Final IMP Administration
|
-77.20 mL
Standard Deviation 982.19
|
513.97 mL
Standard Deviation 653.30
|
153.72 mL
Standard Deviation 993.63
|
539.93 mL
Standard Deviation 659.36
|
Adverse Events
OPC-41061 3.75 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
OPC-41061 7.5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OPC-41061 15 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
OPC-41061 30 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-41061 3.75 mg
n=15 participants at risk
Orally administered at 3.75 mg once daily in maintenance period.
|
OPC-41061 7.5 mg
n=8 participants at risk
Orally administered at 7.5 mg once daily in maintenance period.
|
OPC-41061 15 mg
n=9 participants at risk
Orally administered at 15 mg once daily in maintenance period.
|
OPC-41061 30 mg
n=11 participants at risk
Orally administered at 30 mg once daily in maintenance period.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
Other adverse events
| Measure |
OPC-41061 3.75 mg
n=15 participants at risk
Orally administered at 3.75 mg once daily in maintenance period.
|
OPC-41061 7.5 mg
n=8 participants at risk
Orally administered at 7.5 mg once daily in maintenance period.
|
OPC-41061 15 mg
n=9 participants at risk
Orally administered at 15 mg once daily in maintenance period.
|
OPC-41061 30 mg
n=11 participants at risk
Orally administered at 30 mg once daily in maintenance period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
18.2%
2/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Intestinal infarction
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
18.2%
2/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
22.2%
2/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
General disorders
Malaise
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
General disorders
Thirst
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Infections and infestations
Stitch abscess
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Blood glucose decreased
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Blood osmolarity increased
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Blood urea increased
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Blood uric acid increased
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Electrocardiogram T wave peaked
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Blood urine present
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Weight decreased
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Platelet count increased
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Urine ketone body
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Investigations
Urine output decreased
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
18.2%
2/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
9.1%
1/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.7%
1/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
11.1%
1/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/15 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/9 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
0.00%
0/11 • Treatment-emergent adverse events (TEAEs) were collected from the start of IMP administration up to 10 days after the final IMP administration.
Safety analysis set: all subjects who had been administered the IMP at least once.
|
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