Trial Outcomes & Findings for ONO-4538 Phase I Study in Patients With Solid Tumor (NCT NCT02261285)
NCT ID: NCT02261285
Last Updated: 2024-05-06
Results Overview
Cmax was the maximum serum concentration of ONO-4538 after the single administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.
Results posted on
2024-05-06
Participant Flow
Participant milestones
| Measure |
ONO-4538 1 mg/kg
Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 1 mg/kg as an intravenous infusion over approximately 60 minutes.
|
ONO-4538 3 mg/kg
Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 3 mg/kg as an intravenous infusion over approximately 60 minutes.
|
ONO-4538 10 mg/kg
Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 10 mg/kg as an intravenous infusion over approximately 60 minutes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
ONO-4538 1 mg/kg
Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 1 mg/kg as an intravenous infusion over approximately 60 minutes.
|
ONO-4538 3 mg/kg
Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 3 mg/kg as an intravenous infusion over approximately 60 minutes.
|
ONO-4538 10 mg/kg
Subjects with advanced or recurrent solid tumors, received single dose of Nivolumab (ONO-4538) at a dose of 10 mg/kg as an intravenous infusion over approximately 60 minutes.
|
|---|---|---|---|
|
Overall Study
Disease progression
|
0
|
0
|
1
|
Baseline Characteristics
ONO-4538 Phase I Study in Patients With Solid Tumor
Baseline characteristics by cohort
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.5 years
n=5 Participants
|
63.0 years
n=7 Participants
|
52.5 years
n=5 Participants
|
56.0 years
n=4 Participants
|
|
Age, Customized
<65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Customized
>=65-<75 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Customized
>=75 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Height
|
156.60 Centimeter
n=5 Participants
|
161.90 Centimeter
n=7 Participants
|
161.35 Centimeter
n=5 Participants
|
160.85 Centimeter
n=4 Participants
|
|
Weight
|
56.75 Kilogram
n=5 Participants
|
63.40 Kilogram
n=7 Participants
|
57.50 Kilogram
n=5 Participants
|
59.25 Kilogram
n=4 Participants
|
|
BMI
|
22.62 Kilogram per square meter
n=5 Participants
|
23.26 Kilogram per square meter
n=7 Participants
|
21.55 Kilogram per square meter
n=5 Participants
|
22.57 Kilogram per square meter
n=4 Participants
|
|
Performance status (Eastern Cooperative Oncology Group)
PS 0
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Performance status (Eastern Cooperative Oncology Group)
PS 1
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Type of primary cancer
Lung cancer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Type of primary cancer
Melanoma
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Type of primary cancer
Salivary gland cancer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Type of primary cancer
Rectal cancer
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Type of primary cancer
Renal cell carcinoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of primary cancer
Pancreatic cancer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of primary cancer
Gastric cancer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of primary cancer
Nasal cavity cancer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of primary cancer
Nasopharyngeal carcinoma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of primary cancer
Colon cancer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Type of primary cancer
Sarcoma
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
History of surgery
Yes
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
History of surgery
No
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
History of radiotherapy
Yes
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
History of radiotherapy
No
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
History of chemotherapy
None
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
History of chemotherapy
1 regimen
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
History of chemotherapy
2 regimens
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
History of chemotherapy
3 regimens
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
History of chemotherapy
4 regimens
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
History of chemotherapy
5 regimens
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
History of chemotherapy
6 regimens
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.Cmax was the maximum serum concentration of ONO-4538 after the single administration.
Outcome measures
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
|---|---|---|---|
|
PK Outcome: Cmax of ONO-4538
|
26.0 µg/mL
Standard Deviation 4.29
|
64.3 µg/mL
Standard Deviation 22.5
|
242.0 µg/mL
Standard Deviation 66.7
|
PRIMARY outcome
Timeframe: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.Tmax was the time to reach the Cmax.
Outcome measures
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
|---|---|---|---|
|
PK Outcome: Tmax of ONO-4538
|
3.02 hours
Interval 1.07 to 9.0
|
3.00 hours
Interval 1.0 to 8.78
|
2.99 hours
Interval 1.0 to 8.62
|
PRIMARY outcome
Timeframe: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.AUC21day was the area under serum concentration-time curve of ONO-4538 from day 0 to day 21 (last measurement).
Outcome measures
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=5 Participants
Refer to "Participant Flow ".
|
|---|---|---|---|
|
AUC21day
|
5110 µg*h/mL
Standard Deviation 952
|
12200 µg*h/mL
Standard Deviation 2060
|
38700 µg*h/mL
Standard Deviation 14200
|
PRIMARY outcome
Timeframe: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.AUCinf was the area under serum concentration-time curve of ONO-4538 extrapolated to infinity.
Outcome measures
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=5 Participants
Refer to "Participant Flow ".
|
|---|---|---|---|
|
AUCinf
|
9180 µg*h/mL
Standard Deviation 3140
|
22800 µg*h/mL
Standard Deviation 10000
|
68100 µg*h/mL
Standard Deviation 34700
|
PRIMARY outcome
Timeframe: 3 weeks: from the start of administration to the end of treatment phase. Actual blood sampling points are pre-dose, 1hr, 3hr, 9hr, 25hr, 49hr, 73hr, 169hr, 337hr, and 504hr.T1/2 was the elimination half-life of serum concentration of ONO-4538.
Outcome measures
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=5 Participants
Refer to "Participant Flow ".
|
|---|---|---|---|
|
T1/2
|
18.3 days
Standard Deviation 6.97
|
19.1 days
Standard Deviation 10.0
|
15.0 days
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: 3 weeks: from the start of administration to the end of treatment phase.Population: Safety Analysis Set
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following exposure to investigational product.
Outcome measures
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
|---|---|---|---|
|
Safety Outcome: The Number of Subjects With Overall Adverse Events
|
5 participants
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 3 weeks: from the start of administration to the end of treatment phase.Population: Safety Analysis Set
Number of subjects with TEAEs leading to death.
Outcome measures
| Measure |
ONO-4538 1 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=6 Participants
Refer to "Participant Flow ".
|
|---|---|---|---|
|
Safety Outcome: The Number of Deaths
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
ONO-4538 1 mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
ONO-4538 3 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ONO-4538 10 mg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ONO-4538 1 mg/kg
n=6 participants at risk
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 participants at risk
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=6 participants at risk
Refer to "Participant Flow ".
|
|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
Other adverse events
| Measure |
ONO-4538 1 mg/kg
n=6 participants at risk
Refer to "Participant Flow ".
|
ONO-4538 3 mg/kg
n=6 participants at risk
Refer to "Participant Flow ".
|
ONO-4538 10 mg/kg
n=6 participants at risk
Refer to "Participant Flow ".
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
50.0%
3/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
General disorders
Chills
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
General disorders
Fatigue
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
33.3%
2/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
50.0%
3/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
0.00%
0/6 • 3 weeks: from the start of administration to the end of treatment phase.
Adverse Events (AEs) were analyzed based on treatment emergent AEs (TEAEs), defined as any event not present prior to initiation of investigational product that first appeared following exposure to investigational product or any event already present that worsened relative to the pre-treatment state following the exposure to investigational product. All-Cause Mortality was defined as incidence of subjects who have died during study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this tiral prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER