Trial Outcomes & Findings for Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact (NCT NCT05376527)
NCT ID: NCT05376527
Last Updated: 2026-04-21
Results Overview
Number of participants with: AEs, SAEs, lethal outcomes, AEs of grade 3 and higher severity, AEs leading to withdrawal, AEs related to IP administration, and Dose Limiting Toxicity. The severity of adverse events was assessed according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0. National Cancer Institute. 2017.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
90 days from the data of the last treatment (for Stage 1 up to 107 days from participation in the study; for Stage 2 up to 129 days from participation in the study
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Cohort 1: Single Dose 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
3
|
3
|
5
|
6
|
4
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
1
|
2
|
1
|
3
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
2
|
1
|
2
|
2
|
5
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1: Single Dose 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Disease Progression
|
1
|
0
|
0
|
1
|
1
|
1
|
1
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
1
|
1
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Requirement of prohibited therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Open Multi-cohort Study of the First Phase of Safety of a Drug Based on Double Recombinant Vaccinia Virus VV-GMCSF-Lact
Baseline characteristics by cohort
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=4 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=5 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=6 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=4 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Age, Continuous
|
47.25 Year
STANDARD_DEVIATION 5.32 • n=13 Participants
|
52.33 Year
STANDARD_DEVIATION 3.21 • n=13 Participants
|
49.33 Year
STANDARD_DEVIATION 12.58 • n=26 Participants
|
63.67 Year
STANDARD_DEVIATION 17.21 • n=15 Participants
|
59.67 Year
STANDARD_DEVIATION 9.71 • n=25 Participants
|
55.67 Year
STANDARD_DEVIATION 12.86 • n=6 Participants
|
48.6 Year
STANDARD_DEVIATION 10.6 • n=17 Participants
|
54.8 Year
STANDARD_DEVIATION 17.8 • n=12 Participants
|
50.2 Year
STANDARD_DEVIATION 5.9 • n=10 Participants
|
53.50 Year
STANDARD_DEVIATION 5.17 • n=22 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
3 Participants
n=26 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=25 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=12 Participants
|
4 Participants
n=10 Participants
|
34 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
3 Participants
n=26 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=25 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=12 Participants
|
4 Participants
n=10 Participants
|
34 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=22 Participants
|
|
ECOG
ECOG = 0
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=22 Participants
|
|
ECOG
ECOG = 1
|
3 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=17 Participants
|
6 Participants
n=12 Participants
|
4 Participants
n=10 Participants
|
26 Participants
n=22 Participants
|
|
ECOG
ECOG = 2
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: 90 days from the data of the last treatment (for Stage 1 up to 107 days from participation in the study; for Stage 2 up to 129 days from participation in the studyNumber of participants with: AEs, SAEs, lethal outcomes, AEs of grade 3 and higher severity, AEs leading to withdrawal, AEs related to IP administration, and Dose Limiting Toxicity. The severity of adverse events was assessed according to CTCAE (Common Terminology Criteria for Adverse Events) Version 5.0. National Cancer Institute. 2017.
Outcome measures
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=4 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=5 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=6 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=4 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Safety Parameters
Subjects with SAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety Parameters
Subjects with AEs
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Safety Parameters
Subjects with AEs of grade 3 and higher severity
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety Parameters
Subjects with AEs leading to withdrawal
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety Parameters
Subjects with AEs related to IP administration
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Safety Parameters
Subjects with lethal outcome
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Parameters
Subjects with Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: plus 3 days to the day of the last treatment for single dose, plus 14 days to the day of the last treatment for multiple dosesDose-limiting toxicity is defined as the occurrence of at least one of the following events following administration of the investigational drug: 1. Grade 3 non-hematologic toxicity according to the CTCAE (excluding alopecia); 2. development of febrile neutropenia (neutrophils \<1.0 × 10⁹/L with a single; 3. rise in body temperature \>38.3°C or a sustained body temperature \>=38°C for more than one hour), or development of a clinically significant systemic infection (a local infection at the site of drug administration or at the biopsy site will not be considered clinically significant); (3) Grade III thrombocytopenia or higher and/or hemorrhagic complications; (4) recurrent or persistent elevation of ALT and/or AST levels to more than 4 times the upper limit of normal.
Outcome measures
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=4 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=5 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=6 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=4 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 216 hours since the last treatmentDetermination of maximum virus concentrations in blood.
Outcome measures
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=4 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=5 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=6 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=4 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Determination of Virus Concentrations in Blood
|
0 copies / mL
Interval 0.0 to 2840.0
|
0 copies / mL
Interval 0.0 to 533.0
|
564 copies / mL
Interval 0.0 to 3800.0
|
4110 copies / mL
Interval 0.0 to 5130.0
|
5950 copies / mL
Interval 5950.0 to 5950.0
|
2385 copies / mL
Interval 0.0 to 4770.0
|
11461 copies / mL
Interval 0.0 to 15690.0
|
3345.5 copies / mL
Interval 880.0 to 13140.0
|
17060 copies / mL
Interval 17060.0 to 17060.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 28 days to the last treatmentPopulation: Geometric mean titer (GMT) of anti-vaccinia virus antibodies at Day 28 after the last IMP administration. This measure represents the systemic immune response to the VV-GMCSF-Lact administration. Since the timepoint of Day 28 was used, number of participants represents only those who stayed in the study till the timepoint.
Determination of the antivirus antibodies titer in the blood 28 days after intratumoral administration.
Outcome measures
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=1 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=3 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=2 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=2 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=1 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=3 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=2 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=1 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Determination of the Antivirus Antibodies Titer in the Blood
|
800 Geometric Mean titer
Standard Deviation 4.2
|
819200 Geometric Mean titer
Standard Deviation NA
Single subject
|
20318.7 Geometric Mean titer
Standard Deviation 119494.2
|
18101.9 Geometric Mean titer
Standard Deviation 1.3
|
4525.5 Geometric Mean titer
Standard Deviation 4205470703337.0
|
409600.0 Geometric Mean titer
Standard Deviation NA
Single subject
|
81274.9 Geometric Mean titer
Standard Deviation 3.1
|
36203.9 Geometric Mean titer
Standard Deviation 8.7
|
204800.0 Geometric Mean titer
Standard Deviation NA
Single subject
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 107 days from participation in the study for Stage 1; up to 129 days from participation in the study for Stage 2Population: Count of Participants achieved the listed RECIST 1.1 responses by the Visit 12
Objective response is defined as per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1): Complete Response - The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Partial Response - At least a 30% decrease in the sum of the longest diameters of target lesions, or all measurable disease has completely disappeared, but a non-measurable component is still present but not progressing. Stable Disease - Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive Disease - At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or new lesions. CT scans were used for visualization.
Outcome measures
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=1 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=1 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=1 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=1 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=2 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=1 Participants
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=3 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=1 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=1 Participants
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Assessment of Objective Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Objective Response
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Objective Response
Stable Disease
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Objective Response
Progressive Disease
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Cohort 1: Single Dose 10^7 PFU
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 2: Single Dose 2 x 10^7 PFU
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: Single Dose 4 x 10^7 PFU
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4: Single Dose 6 x 10^7 PFU
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5: Single Dose 8 x 10^7 PFU
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6: Single Dose 10 x 10^7 PFU
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 7: Multiple Doses 6 x 10^7 PFU
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 8: Multiple Doses 8 x 10^7 PFU
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 9: Multiple Doses 10 x 10^7 PFU
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=4 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=5 participants at risk
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=6 participants at risk
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=4 participants at risk
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer complication
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
Other adverse events
| Measure |
Cohort 1: Single Dose 10^7 PFU
n=4 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of $10\^7$ PFU (0.5 ml) on Day 1.
|
Cohort 2: Single Dose 2 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 2 x 10\^7 PFU (1.0 ml) on Day 1.
|
Cohort 3: Single Dose 4 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 4 x 10\^7 PFU (2.0 ml) on Day 1.
|
Cohort 4: Single Dose 6 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) on Day 1.
|
Cohort 5: Single Dose 8 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) on Day 1.
|
Cohort 6: Single Dose 10 x 10^7 PFU
n=3 participants at risk
Patients received a single intratumoral injection of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) on Day 1.
|
Cohort 7: Multiple Doses 6 x 10^7 PFU
n=5 participants at risk
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 6 x 10\^7 PFU (3.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 8: Multiple Doses 8 x 10^7 PFU
n=6 participants at risk
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 8 x 10\^7 PFU (4.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
Cohort 9: Multiple Doses 10 x 10^7 PFU
n=4 participants at risk
Patients received intratumoral injections of VV-GMCSF-Lact at a dose of 10 x 10\^7 PFU (5.0 ml) per injection. The drug was administered on Days 1, 8,15, and 22 (total of 4 administrations).
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm complication
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Reproductive system and breast disorders
Nipple disorder
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour inflammation
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Musculoskeletal and connective tissue disorders
Femoral neck fracture
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Skin and subcutaneous tissue disorders
Skin cyst infected
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Muscular weakness
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin metastases
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Reproductive system and breast disorders
Groin pain
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Headache
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
2/6 • Number of events 3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
40.0%
2/5 • Number of events 3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Body temperature increased
|
50.0%
2/4 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Chills
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
66.7%
2/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
66.7%
2/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
60.0%
3/5 • Number of events 3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Injection site erythema
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Breast pain
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
66.7%
2/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Investigations
Leukocyturia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Cardiac disorders
Electrocardiogram repolarisation abnormality
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Cardiac disorders
Electrocardiogram P wave abnormal
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Tumour pain
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Nervous system disorders
Peripheral neuropathy
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Vaccination site lymphadenopathy
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Cough
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
16.7%
1/6 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Chest pain
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Injection site pruritus
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
66.7%
2/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
20.0%
1/5 • Number of events 3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
50.0%
3/6 • Number of events 6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
66.7%
2/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
100.0%
3/3 • Number of events 7 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
100.0%
5/5 • Number of events 16 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
66.7%
4/6 • Number of events 11 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
50.0%
2/4 • Number of events 6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 2 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/3 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
33.3%
1/3 • Number of events 1 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/5 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/6 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
0.00%
0/4 • Whole study: up to day 93 in the Single Dose Period and up to day 115 in the Multiple Doses Period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI and Institution must keep all Study data confidential for 7 years after Contract termination. Disclosure to third parties or non-Study use requires Sponsor's prior written consent. Standard exceptions apply (public domain, legal mandate). Publication, presentation, or use of Study methods/results is permitted only after obtaining Sponsor's prior written consent. The Sponsor will publish results regardless of outcome if required by law.
- Publication restrictions are in place
Restriction type: OTHER