Trial Outcomes & Findings for Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML) (NCT NCT01349049)
NCT ID: NCT01349049
Last Updated: 2020-03-02
Results Overview
Complete remission (CR): Has bone marrow regenerating normal cells, achieve a morphologic leukemia-free state, Complete remission with incomplete platelet recovery (CRp): CR except for incomplete platelet recovery, Complete remission with incomplete recovery (CRi): CR except for incomplete hematological recovery with residual neutropenia, Partial response (PR): bone marrow generates normal hematopoietic cells, evidence of peripheral recovery with no or a few regenerating circulating blasts. Decrease of ≥50% of blasts in bone marrow aspirate, total marrow blasts between 5% -25%, Non-response (NR) were assessed using modified International Working Group (IWG) response criteria for AML. Successfully (BTT) patients and successfully BTT patients (CR, CRp, or CRi) are also reported. Successfully BTT is defined as any patient who discontinued PLX3397 treatment specifically for the purpose of undergoing a hematopoietic stem cell transplant and who subsequently received the planned transplant.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
90 participants
Primary outcome timeframe
1 year post dose
Results posted on
2020-03-02
Participant Flow
A total of 90 participants (34 in Part 1 and 56 in part 2) were enrolled in the study and received PLX3397.
The study participants enrolled are patients with relapsed or refractory Flt3-ITD+ AML, or newly diagnosed Flt3-ITD + AML patients who either refused or were considered not to be appropriate candidates for chemotherapy.
Participant milestones
| Measure |
Part 1: 800 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day
|
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day
|
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
3
|
3
|
3
|
6
|
5
|
4
|
56
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
3
|
3
|
3
|
6
|
5
|
4
|
55
|
Reasons for withdrawal
| Measure |
Part 1: 800 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day
|
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day
|
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
3
|
5
|
3
|
2
|
2
|
2
|
3
|
2
|
33
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
3
|
1
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Hematopoietic stem cell transplant
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
4
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
Baseline Characteristics
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Part 1: 5000 mg/Day
n=4 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
|
Total
n=90 Participants
Total of all reporting groups
|
Part 1: 800 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day
|
Part 1: 1000 mg/Day
n=7 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 1: 1200 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day
|
Part 1: 1400 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day
|
Part 1: 2000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day
|
Part 1: 3000 mg/Day
n=6 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day
|
Part 1: 4000 mg/Day
n=5 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Region of Enrollment
United States
|
4 participants
n=24 Participants
|
56 participants
n=42 Participants
|
90 participants
n=42 Participants
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=8 Participants
|
5 participants
n=8 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 2.5 • n=24 Participants
|
55.9 years
STANDARD_DEVIATION 14.6 • n=42 Participants
|
57.7 years
STANDARD_DEVIATION 14.72 • n=42 Participants
|
58.0 years
STANDARD_DEVIATION 28.2 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 18.5 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 19.7 • n=4 Participants
|
70.7 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
61.0 years
STANDARD_DEVIATION 9.7 • n=8 Participants
|
54.8 years
STANDARD_DEVIATION 14.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 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
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
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=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
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=24 Participants
|
7 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
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
|
PRIMARY outcome
Timeframe: 1 year post dosePopulation: Efficacy analyses were conducted in the Part 2 Efficacy Population.
Complete remission (CR): Has bone marrow regenerating normal cells, achieve a morphologic leukemia-free state, Complete remission with incomplete platelet recovery (CRp): CR except for incomplete platelet recovery, Complete remission with incomplete recovery (CRi): CR except for incomplete hematological recovery with residual neutropenia, Partial response (PR): bone marrow generates normal hematopoietic cells, evidence of peripheral recovery with no or a few regenerating circulating blasts. Decrease of ≥50% of blasts in bone marrow aspirate, total marrow blasts between 5% -25%, Non-response (NR) were assessed using modified International Working Group (IWG) response criteria for AML. Successfully (BTT) patients and successfully BTT patients (CR, CRp, or CRi) are also reported. Successfully BTT is defined as any patient who discontinued PLX3397 treatment specifically for the purpose of undergoing a hematopoietic stem cell transplant and who subsequently received the planned transplant.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).
CR
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).
CRp
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).
CRi
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).
PR
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).
NR
|
—
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).
Successful BTT patients
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).
Successful BTT patient (CR, CRp, or CRi)
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 year post dosePopulation: Time-to-event analyses were assessed in the Part 2 Efficacy Population.
Median survival estimates were based on the Kaplan-Meier method. In the event disease progression/relapse or death was not documented prior to study termination, endpoints were censored at the date of last evaluable tumor assessment. Duration of remission, duration of complete remission, and disease-free survival, initial response was based on the modified response criteria. Duration of complete remission was defined as the number of days from the date of initial CR, CRp, or CRi response to the date of first documented disease relapse or death, whichever occurred first. Disease-free survival was defined as the number of days from the date of initial CR, CRp, or CRi to the date of documented disease relapse or death from any cause, whichever occurred first.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)
Duration of remission
|
—
|
91 days
Interval 43.0 to 337.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)
Duration of complete remission
|
—
|
289 days
Interval 289.0 to 289.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)
Progression-free survival
|
—
|
48 days
Interval 30.0 to 58.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)
Disease-free survival
|
—
|
289 days
Interval 289.0 to 289.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)
Overall survival
|
—
|
112 days
Interval 77.0 to 150.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year post dosePopulation: Efficacy analyses were conducted in the Part 2 Efficacy Population.
Modified International Working Group Response Criteria for Acute Myeloid Leukemia defines Partial Remission (PR) as the following: Partial Remission (PR): Patients must have bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. In addition, patients do not need to be Red Blood Cell (RBC) or platelet transfusion independent.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR) During Treatment With PLX3397 (Dose Expansion, Part 2)
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year post dosePopulation: Efficacy analyses were conducted in the Part 2 Efficacy Population.
Complete Remission (CR): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 109/L (1000/μL); platelet count \>100 x 109/L (100000/μL); red cell transfusion independent CR with incomplete recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 x 109/L) or thrombocytopenia Partial Remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5-25%; decrease of pretreatment bone marrow blast percentage by at least 50%.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)
CR
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)
CRi
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)
PR
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)
NR
|
—
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year post dosePopulation: Adverse events were assessed in the Safety Population.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
n=7 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
n=6 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
n=5 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
n=4 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
At least 1 AE
|
7 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
56 Participants
|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
AE resulting in death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
At least 1 treatment-related AE
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
49 Participants
|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
AE that lead to change in drug administration
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
28 Participants
|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
At least 1 AE with CTCAE Grade >=3
|
7 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
50 Participants
|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
Serious Adverse Event (SAE)or other significant AE
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
39 Participants
|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
At least 1 treatment-related Serious Adverse Event
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
|
Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)
SAE leading to discontinuation of study drug
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 year post dosePopulation: Adverse events were assessed in the Safety Population.
Data reported are Treatment-Related Treatment Emergent Adverse Events that are ≥15% Occurrence in all patients.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
n=7 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
n=6 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
n=5 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
n=4 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Fatigue
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
18 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
At least 1 treatment-related AE
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
49 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Nausea
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
21 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Diarrhoea
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
19 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Vomiting
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
15 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Decreased appetite
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
16 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Anaemia
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Aspartate aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
|
Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Dysgeusia
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 year post dosePopulation: Adverse events were assessed in the Safety Population.
Data reported are Treatment Emergent Adverse Events with a CTCAE Grade ≥3 During Treatment that are ≥10% Occurrence in all patients.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
n=7 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
n=6 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
n=5 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
n=4 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
At least 1 AE with CTCAE Grade ≥3
|
7 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
50 Participants
|
|
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Febrile neutropenia
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
22 Participants
|
|
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Anaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Thrombocytopenia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Sepsis
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
|
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
|
Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Fatigue
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 year post dosePopulation: Adverse events were assessed in the Safety Population.
Outcome measures
| Measure |
Part 1: 1000 mg/Day
n=7 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
n=3 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
n=6 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
n=5 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
n=4 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
n=56 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hyperphosphataemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
INR increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Lipase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hyperuricaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hyponatraemia
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Myeloblast count increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Troponin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
White blood cell count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hypernatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood urea decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood uric acid increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Leukopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hyperchloraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hyperkalaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Bilirubin conjugated increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blast cell count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood albumin decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood chloride increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood creatinine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood fibrinogen decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Carbon monoxide diffusing capacity decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Gamma glutamyl transferase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Globulins increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Anaemia
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hypokalaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
13 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
13 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Thrombocytopenia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hypomagnesmia
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hypocalcaemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
12 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood alkaline phosphatase increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hyperglycaemia
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood bilirubin increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hypoalbuminaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hypophosphataemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Transaminases increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
White blood cell count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Lymphocyte count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Leukocytosis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Blood cholesterol increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Hyperbilirubinaemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)
Activated partial thromboplastin time prolonged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year post dosePopulation: Efficacy analyses were assessed in Part 2 Efficacy Population
Outcome measures
| Measure |
Part 1: 1000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day
|
Part 2: 3000 mg/Day
n=11 Participants
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 1200 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
A Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)
Time to First Response
|
—
|
29 days
Interval 26.0 to 30.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
A Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)
Time to Best Response
|
—
|
30 days
Interval 26.0 to 55.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: 800 mg/Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: 1000 mg/Day
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1: 1200 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: 1400 mg/Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: 2000 mg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: 3000 mg/Day
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: 4000 mg/Day
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1: 5000 mg/Day
Serious events: 4 serious events
Other events: 4 other events
Deaths: 1 deaths
Part 2: 3000 mg/Day
Serious events: 39 serious events
Other events: 56 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Part 1: 800 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day.
|
Part 1: 1000 mg/Day
n=7 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day.
|
Part 1: 1200 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
n=6 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
n=5 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
n=4 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
n=56 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.1%
9/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Device related infection
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
57.1%
4/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
30.4%
17/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Actinomycosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
Other adverse events
| Measure |
Part 1: 800 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 800 mg/day.
|
Part 1: 1000 mg/Day
n=7 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1000 mg/day.
|
Part 1: 1200 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1200 mg/day.
|
Part 1: 1400 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 1400 mg/day.
|
Part 1: 2000 mg/Day
n=3 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 2000 mg/day.
|
Part 1: 3000 mg/Day
n=6 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
Part 1: 4000 mg/Day
n=5 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 4000 mg/day.
|
Part 1: 5000 mg/Day
n=4 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 5000 mg/day.
|
Part 2: 3000 mg/Day
n=56 participants at risk
Participants with acute myeloid leukemia (AML), either relapsed/refractory or newly diagnosed and unfit to receive chemotherapy, received PLX3397 3000 mg/day.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
80.0%
4/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
48.2%
27/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
75.0%
3/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
24/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
3/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
3/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
75.0%
3/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
32.1%
18/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
8/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
17.9%
10/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Mouth ulceration
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Angina bullosa haemorrhagica
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haematochezia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
8.9%
5/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Melaena
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Proctalgia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Proctitis
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Retching
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
3/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
75.0%
3/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
44.6%
25/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
3/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
8/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
8/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
10.7%
6/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Mucosal dryness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Malaise
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Hypothermia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Infusion site erythema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Infusion site swelling
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Nodule
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
General disorders
Oedema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
42.9%
3/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
35.7%
20/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.2%
13/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
8/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
8.9%
5/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
17.9%
10/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.1%
9/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
8/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
4/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.2%
13/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
71.4%
5/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
100.0%
3/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
39.3%
22/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
40.0%
2/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
75.0%
3/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
26.8%
15/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
75.0%
3/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.1%
9/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Spleen disorder
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
8.9%
5/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
10.7%
6/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
17.9%
10/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Clostridial infection
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Device related infection
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
10.7%
6/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Enterobacter infection
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia klebsiella
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Skin candida
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
8.9%
5/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.1%
9/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
17.9%
10/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Facial wasting
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
10.7%
6/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.1%
9/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Somnolence
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
8.9%
5/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Trichiasis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
23.2%
13/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
10.7%
6/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
17.9%
10/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
8.9%
5/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
21.4%
12/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Myeloblast count increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
10.7%
6/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Spleen palpable
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
12.5%
7/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
8.9%
5/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
28.6%
2/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Agitation
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Mental status changes
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
7.1%
4/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
50.0%
2/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
8/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
5.4%
3/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
20.0%
1/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
2/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
66.7%
2/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
3.6%
2/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
14.3%
1/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hepatic lesion
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Hepatobiliary disorders
Liver disorder
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
1.8%
1/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
16.7%
1/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
25.0%
1/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia cutis
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
|
Infections and infestations
Influenza A
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/7 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
33.3%
1/3 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/6 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/5 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/4 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
|
0.00%
0/56 • Adverse event data were collected from after the first dose to 30 days after the last dose.
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place