Trial Outcomes & Findings for Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma (NCT NCT02895360)
NCT ID: NCT02895360
Last Updated: 2023-05-10
Results Overview
First 28-day treatment cycle dose limiting toxicities (DLT) graded according to CTCAE in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
28 day cycle
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
Phase 1 - 30 mg/m² Cohort
BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
|
Phase 1 - 45 mg/m² Cohort
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 as 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|
|
Phase 1 - 30 mg/m² Cohort
STARTED
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 - 30 mg/m² Cohort
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 - 30 mg/m² Cohort
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 - 45 mg/m² Cohort
STARTED
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1 - 45 mg/m² Cohort
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 - 45 mg/m² Cohort
NOT COMPLETED
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1 - 70 mg/m² Cohort
STARTED
|
0
|
0
|
9
|
0
|
0
|
0
|
|
Phase 1 - 70 mg/m² Cohort
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 - 70 mg/m² Cohort
NOT COMPLETED
|
0
|
0
|
9
|
0
|
0
|
0
|
|
Phase 1 - 90 mg/m² Cohort
STARTED
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Phase 1 - 90 mg/m² Cohort
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 - 90 mg/m² Cohort
NOT COMPLETED
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Phase 2a
STARTED
|
0
|
0
|
0
|
0
|
11
|
12
|
|
Phase 2a
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2a
NOT COMPLETED
|
0
|
0
|
0
|
0
|
11
|
12
|
Reasons for withdrawal
| Measure |
Phase 1 - 30 mg/m² Cohort
BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
|
Phase 1 - 45 mg/m² Cohort
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 as 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|
|
Phase 1 - 30 mg/m² Cohort
Progressive disease
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 - 45 mg/m² Cohort
Progressive disease
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1 - 70 mg/m² Cohort
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Phase 1 - 70 mg/m² Cohort
Progressive disease
|
0
|
0
|
7
|
0
|
0
|
0
|
|
Phase 1 - 90 mg/m² Cohort
Progressive disease
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Phase 2a
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 2a
Progressive disease
|
0
|
0
|
0
|
0
|
11
|
11
|
Baseline Characteristics
Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
30 mg/m² Cohort
n=4 Participants
BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
|
45 mg/m² Cohort
n=3 Participants
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
70 mg/m² Cohort
n=9 Participants
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
90 mg/m² Cohort
n=4 Participants
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=11 Participants
BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
n=12 Participants
BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.3 Years
STANDARD_DEVIATION 3.30 • n=5 Participants
|
61.0 Years
STANDARD_DEVIATION 0 • n=7 Participants
|
59.6 Years
STANDARD_DEVIATION 10.53 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 7.26 • n=4 Participants
|
64.7 Years
STANDARD_DEVIATION 8.78 • n=21 Participants
|
59.3 Years
STANDARD_DEVIATION 7.45 • n=8 Participants
|
60.7 Years
STANDARD_DEVIATION 8.25 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
4 participants
n=4 Participants
|
11 participants
n=21 Participants
|
12 participants
n=8 Participants
|
43 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 28 day cyclePopulation: MTD-determining population in Phase 1: All patients who meet the following minimum criteria during the first 28-day treatment cycle (Cycle 1) * received at least one partial or complete dose of BAL101553 and has experienced a DLT; * received all three doses of BAL101553 without experiencing a DLT (including the ability to initiate treatment Cycle 2), have been observed for ≥ 28 days following the first dose, and have been evaluated for safety.
First 28-day treatment cycle dose limiting toxicities (DLT) graded according to CTCAE in the MTD-determining population in Phase 1 based on the number of participants with adverse effects as measure of tolerability at various dose levels
Outcome measures
| Measure |
MTD-determining Population in Phase 1
n=15 Participants
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
|
Phase 1 - 45 mg/m² Cohort
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
90 mg/m² Cycle 1 Day 1
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
|
90 mg/m² Cycle 2 Day 1
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of BAL101553
|
70 mg/m²
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: TEAEs with onset on or after Day 1 of the study and until 28 days after the last dosePopulation: All patients who receive at least one full or partial dose of BAL101553 and had at least one post-baseline safety assessment is included in the safety analysis population.
TEAEs are defined as all events occurring after BAL101553 treatment begins, up to 28 days after last study drug administration according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Outcome measures
| Measure |
MTD-determining Population in Phase 1
n=4 Participants
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
|
Phase 1 - 45 mg/m² Cohort
n=3 Participants
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=9 Participants
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=4 Participants
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=11 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
n=12 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
90 mg/m² Cycle 1 Day 1
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
|
90 mg/m² Cycle 2 Day 1
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication
Patients with ≥1 related AE
|
2 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication
Patients with CTCAE Grade 3/4 or severe related AE
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Safety and Tolerability of BAL101553 Treatment Based on Number of Patients With Related Treatment-emergent Adverse Events (TEAEs) in the Phase 1 and Phase 2a Safety Population at Various Dose Levels and Indication
Patients with ≥1 related serious AE
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 168 hours post-dose at Day 1 of Cycle 1 and Cycle 2 in each cohort in Phase 1, 28-day cyclesPopulation: The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.
Pharmacokinetic parameter "Area under the plasma concentration versus time curve" AUC0-last (of BAL101553 and BAL27862 has been assessed after a 48-hour IV infusion. Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
Outcome measures
| Measure |
MTD-determining Population in Phase 1
n=4 Participants
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
|
Phase 1 - 45 mg/m² Cohort
n=3 Participants
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=3 Participants
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=2 Participants
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=9 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
n=6 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
90 mg/m² Cycle 1 Day 1
n=4 Participants
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
|
90 mg/m² Cycle 2 Day 1
n=3 Participants
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
|
|---|---|---|---|---|---|---|---|---|
|
AUC of BAL101553 and BAL27862
BAL101553
|
1430 h*ng/mL
Geometric Coefficient of Variation 43.9
|
1310 h*ng/mL
Geometric Coefficient of Variation 47.6
|
2260 h*ng/mL
Geometric Coefficient of Variation 43.9
|
1890 h*ng/mL
Geometric Coefficient of Variation 13.3
|
3560 h*ng/mL
Geometric Coefficient of Variation 45.9
|
3550 h*ng/mL
Geometric Coefficient of Variation 43.1
|
4810 h*ng/mL
Geometric Coefficient of Variation 74.0
|
4150 h*ng/mL
Geometric Coefficient of Variation 67.5
|
|
AUC of BAL101553 and BAL27862
BAL27862
|
1730 h*ng/mL
Geometric Coefficient of Variation 37.8
|
2250 h*ng/mL
Geometric Coefficient of Variation 58.2
|
3440 h*ng/mL
Geometric Coefficient of Variation 45.1
|
3920 h*ng/mL
Geometric Coefficient of Variation 57.7
|
7720 h*ng/mL
Geometric Coefficient of Variation 44.6
|
6640 h*ng/mL
Geometric Coefficient of Variation 49.3
|
10400 h*ng/mL
Geometric Coefficient of Variation 37.2
|
10700 h*ng/mL
Geometric Coefficient of Variation 39.3
|
SECONDARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.Population: The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.
Pharmacokinetic parameter "Peak Plasma Concentration" Cmax of BAL101553 and BAL27862. Lisavanbulin (BAL101553) is the prodrug of avanbulin (BAL27862).
Outcome measures
| Measure |
MTD-determining Population in Phase 1
n=4 Participants
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
|
Phase 1 - 45 mg/m² Cohort
n=3 Participants
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=3 Participants
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=2 Participants
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=9 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
n=6 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
90 mg/m² Cycle 1 Day 1
n=4 Participants
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
|
90 mg/m² Cycle 2 Day 1
n=3 Participants
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of BAL101553 and BAL27862
BAL101553
|
43.0 ng/mL
Geometric Coefficient of Variation 22.9
|
44.2 ng/mL
Geometric Coefficient of Variation 15.8
|
69.3 ng/mL
Geometric Coefficient of Variation 19.3
|
60.9 ng/mL
Geometric Coefficient of Variation 4.3
|
119 ng/mL
Geometric Coefficient of Variation 34.5
|
111 ng/mL
Geometric Coefficient of Variation 34.9
|
174 ng/mL
Geometric Coefficient of Variation 63.6
|
198 ng/mL
Geometric Coefficient of Variation 76.8
|
|
Cmax of BAL101553 and BAL27862
BAL27862
|
45.7 ng/mL
Geometric Coefficient of Variation 30.2
|
52.7 ng/mL
Geometric Coefficient of Variation 45.8
|
76.8 ng/mL
Geometric Coefficient of Variation 18.6
|
76.2 ng/mL
Geometric Coefficient of Variation 43.1
|
144 ng/mL
Geometric Coefficient of Variation 25.7
|
120 ng/mL
Geometric Coefficient of Variation 41.2
|
223 ng/mL
Geometric Coefficient of Variation 44.7
|
199 ng/mL
Geometric Coefficient of Variation 40.4
|
SECONDARY outcome
Timeframe: Pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 52, 54, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 1 and pre-dose, and 0.5, 1, 2, 4, 8, 24, 30, 48, 72 h, and 168 h after the start of study-drug infusion on Day 1 of Cycle 2.Population: The PK analysis set includes all patients who received at least one partial or complete dose of study drug and had at least one post-baseline PK assessment.
Pharmacokinetic parameter "Time to Peak Plasma Concentration" Tmax of BAL101553 and BAL27862
Outcome measures
| Measure |
MTD-determining Population in Phase 1
n=4 Participants
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
|
Phase 1 - 45 mg/m² Cohort
n=3 Participants
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=3 Participants
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=2 Participants
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=9 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
n=6 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
90 mg/m² Cycle 1 Day 1
n=4 Participants
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
|
90 mg/m² Cycle 2 Day 1
n=3 Participants
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
|
|---|---|---|---|---|---|---|---|---|
|
Tmax of BAL101553 and BAL27862
BAL101553
|
39.0 hours
Interval 24.0 to 48.0
|
30.0 hours
Interval 24.0 to 48.0
|
29.0 hours
Interval 4.03 to 30.0
|
27.1 hours
Interval 24.2 to 30.0
|
4.00 hours
Interval 1.0 to 24.1
|
1.56 hours
Interval 1.0 to 4.05
|
2.53 hours
Interval 1.03 to 46.5
|
1.17 hours
Interval 1.0 to 3.95
|
|
Tmax of BAL101553 and BAL27862
BAL27862
|
48.0 hours
Interval 30.1 to 48.0
|
48.0 hours
Interval 24.0 to 52.9
|
48.0 hours
Interval 29.0 to 48.1
|
47.5 hours
Interval 47.2 to 47.9
|
47.6 hours
Interval 29.1 to 52.1
|
46.6 hours
Interval 7.5 to 54.7
|
46.2 hours
Interval 23.8 to 47.5
|
47.4 hours
Interval 46.7 to 47.4
|
SECONDARY outcome
Timeframe: Relative oral bioavailability, calculated as dose-normalized AUC0-τ following oral administration on Cycle 2 Day 21 divided by dose normalized AUC0-∞ following IV administration on Cycle 1 Day 1 for each cohort.Population: Patients with both Cycle 1 Day 1 AUC0-∞ and Cycle 2 Day 1 AUC0-τ evaluations
Ratio of AUCs of avanbulin after oral and IV administration (relative bioavailability) of BAL101553 (lisavanbulin) which is the prodrug of avanbulin (BAL27862)
Outcome measures
| Measure |
MTD-determining Population in Phase 1
n=1 Participants
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
|
Phase 1 - 45 mg/m² Cohort
n=1 Participants
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=3 Participants
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=1 Participants
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
90 mg/m² Cycle 1 Day 1
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
|
90 mg/m² Cycle 2 Day 1
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
|
|---|---|---|---|---|---|---|---|---|
|
Bioavailability of Daily Oral BAL101553 Measured by BAL27862 in Phase 1
|
1.11 Ratio
Standard Deviation 0
|
1.32 Ratio
Standard Deviation 0
|
0.796 Ratio
Standard Deviation 18.9
|
0.893 Ratio
Standard Deviation 0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 day cyclesPopulation: FAP: Patients who receive at least one partial or complete dose of BAL101553. EEP: Patients with progressive disease who completed at least Cycle 1 dosing and at least one on-study tumor assessment (clinical or radiological by RECIST v1.1 or RANO criteria) Patients with stable disease, partial or complete response, based on a radiological assessment by RECIST v1.1 or RANO criteria at the end of Cycle 2, with at least 4 doses of study drug in the first two cycles.
The objective response rate (ORR) was calculated using the efficacy evaluable populations (EEPs in Phase 2a) and the full analysis population (FAP in Phase 1 and Phase 2a) based on RECIST v1.1 guidelines (defines criteria for the radiological assessment in tumor response) for patients with solid tumors (excluding GBM (glioblastoma)) and RANO criteria (assessment Incorporating MRI and clinical factors) for patients with GBM. ORR = Rate of complete and partial responses
Outcome measures
| Measure |
MTD-determining Population in Phase 1
n=20 Participants
All patients meeting the criteria of the MTD-determining population in Phase 1 during the first 28-day treatment cycle with intravenous BAL101553 at doses of 30, 45, 70 and 90 mg/m²
|
Phase 1 - 45 mg/m² Cohort
n=11 Participants
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=8 Participants
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=12 Participants
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=8 Participants
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
BAL101553 at 70 mg/m² (MTD)
BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
90 mg/m² Cycle 1 Day 1
BAL101553 90 mg/m² Cohort Cycle 1 Day 1
|
90 mg/m² Cycle 2 Day 1
BAL101553 90 mg/m² Cohort Cycle 2 Day 1
|
|---|---|---|---|---|---|---|---|---|
|
Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria
Progressive disease
|
15 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria
Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria
Complete response
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria
Partial response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Anti-tumor Activity of BAL101553 by Best Response Rate Per RECIST / RANO Criteria
Stable disease
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
Adverse Events
Phase 1 - 30 mg/m² Cohort
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1 - 45 mg/m² Cohort
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 - 70 mg/m² Cohort
Serious events: 7 serious events
Other events: 9 other events
Deaths: 3 deaths
Phase 1 - 90 mg/m² Cohort
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2a - Ovarian Cancer Cohort
Serious events: 4 serious events
Other events: 11 other events
Deaths: 3 deaths
Phase 2a - Recurrent Glioblastoma Cohort
Serious events: 5 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1 - 30 mg/m² Cohort
n=4 participants at risk
BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
|
Phase 1 - 45 mg/m² Cohort
n=3 participants at risk
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=9 participants at risk
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=4 participants at risk
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=11 participants at risk
BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
n=12 participants at risk
BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
16.7%
2/12 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Asthenia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
Other adverse events
| Measure |
Phase 1 - 30 mg/m² Cohort
n=4 participants at risk
BAL101553 30 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 30 mg/m².
|
Phase 1 - 45 mg/m² Cohort
n=3 participants at risk
BAL101553 45 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 45 mg/m².
|
Phase 1 - 70 mg/m² Cohort
n=9 participants at risk
BAL101553 70 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 70 mg/m².
|
Phase 1 - 90 mg/m² Cohort
n=4 participants at risk
BAL101553 90 mg/m² intravenously over 48 hours on Days 1, 8 and 15 of each (at least one) 28-day treatment cycle. During cycle 2, oral BAL101553 was administered on study days 15-21. The oral dose was selected to match the weekly IV dose of 90 mg/m².
|
Phase 2a - Ovarian Cancer Cohort
n=11 participants at risk
BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
Phase 2a - Recurrent Glioblastoma Cohort
n=12 participants at risk
BAL101553 at 70 mg/m² (MTD) BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle
|
|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Troponin T increased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
16.7%
2/12 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
Weight increased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
27.3%
3/11 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
3/12 • Number of events 5 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Hemianaesthesia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Neurologic neglect syndrome
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
27.3%
3/11 • Number of events 5 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
16.7%
2/12 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 7 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
3/9 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
36.4%
4/11 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
44.4%
4/9 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
50.0%
2/4 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
54.5%
6/11 • Number of events 9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
18.2%
2/11 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
44.4%
4/9 • Number of events 5 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
50.0%
2/4 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
54.5%
6/11 • Number of events 7 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
16.7%
2/12 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
27.3%
3/11 • Number of events 6 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
50.0%
2/4 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
4/12 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
18.2%
2/11 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
18.2%
2/11 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
36.4%
4/11 • Number of events 5 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
27.3%
3/11 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
16.7%
2/12 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
16.7%
2/12 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
18.2%
2/11 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
44.4%
4/9 • Number of events 7 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
75.0%
3/4 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
54.5%
6/11 • Number of events 6 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
50.0%
2/4 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
27.3%
3/11 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
22.2%
2/9 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Lip infection
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Localised infection
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Rhinitis
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
16.7%
2/12 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
27.3%
3/11 • Number of events 6 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Chest pain
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Device related thrombosis
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
66.7%
2/3 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
88.9%
8/9 • Number of events 9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
75.0%
3/4 • Number of events 5 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
54.5%
6/11 • Number of events 14 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
4/12 • Number of events 4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Localised oedema
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
18.2%
2/11 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
33.3%
1/3 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
50.0%
2/4 • Number of events 2 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
9.1%
1/11 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
11.1%
1/9 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
50.0%
2/4 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
36.4%
4/11 • Number of events 7 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
8.3%
1/12 • Number of events 1 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/4 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/9 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
25.0%
1/4 • Number of events 3 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/11 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
0.00%
0/12 • First dose of study drug through 28 days after the administration of the last dose
TEAEs with onset on or after Day 1 of the study and until 28 days after the last dose.
|
Additional Information
Thomas Kaindl, MD, Global Medical Director, Oncology
Basilea Pharmaceutica International Ltd.
Phone: +41615671505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60