Trial Outcomes & Findings for A Study Of PF-06664178 In Patients With Advanced Solid Tumors (NCT NCT02122146)
NCT ID: NCT02122146
Last Updated: 2018-02-19
Results Overview
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Day 1 up to Day 21
Results posted on
2018-02-19
Participant Flow
A total of 38 patients were screened, among which 31 were assigned to study treatment.
Participant milestones
| Measure |
PF-06664178 0.15 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Escalation
STARTED
|
2
|
2
|
4
|
4
|
4
|
6
|
1
|
8
|
|
Part 1: Dose Escalation
COMPLETED
|
1
|
1
|
2
|
3
|
3
|
5
|
0
|
6
|
|
Part 1: Dose Escalation
NOT COMPLETED
|
1
|
1
|
2
|
1
|
1
|
1
|
1
|
2
|
|
Part 2: Maximum Tolerated Dose
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Maximum Tolerated Dose
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2: Maximum Tolerated Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Expansion
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
PF-06664178 0.15 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Escalation
Death
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 1: Dose Escalation
Other
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
Baseline Characteristics
A Study Of PF-06664178 In Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
PF-06664178 0.15 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
n=1 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
75 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
61 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 20 • n=4 Participants
|
46 years
STANDARD_DEVIATION 11 • n=21 Participants
|
53.7 years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
63 years
STANDARD_DEVIATION 0 • n=8 Participants
|
61.1 years
STANDARD_DEVIATION 6.6 • n=24 Participants
|
57.1 years
STANDARD_DEVIATION 13.2 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 21Population: All enrolled participants who started treatment. One of participants that experienced DLTs in PF-06664178 4.80mg/kg group was a late DLT that occurred at the beginning of Cycle 2 and was classified as a late DLT.
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Outcome measures
| Measure |
PF-06664178 0.15 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
n=1 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
|---|---|---|---|---|---|---|---|---|
|
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
No
|
2 participants
|
2 participants
|
4 participants
|
4 participants
|
4 participants
|
4 participants
|
0 participants
|
4 participants
|
|
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Yes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 21Population: No participant was analyzed due to study termination
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)Population: No participant was analyzed due to study termination
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)Population: All enrolled participants who started treatment
An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.
Outcome measures
| Measure |
PF-06664178 0.15 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
n=1 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1]
|
2 participants
|
2 participants
|
4 participants
|
4 participants
|
4 participants
|
6 participants
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)Population: All enrolled participants who started treatment.
Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.
Outcome measures
| Measure |
PF-06664178 0.15 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
n=1 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities[Part 1]
|
1 participants
|
2 participants
|
4 participants
|
4 participants
|
4 participants
|
6 participants
|
0 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatmentPopulation: All enrolled participants who started treatment
Number of participants with the presence of anti-PF-06664178 antibodies
Outcome measures
| Measure |
PF-06664178 0.15 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
n=1 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Incidence of Anti-PF-06664178-Antibodies[Part 1]
|
2 participants
|
2 participants
|
4 participants
|
4 participants
|
4 participants
|
6 participants
|
0 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatmentPopulation: No participant was analyzed due to study termination
Number of participants with the presence of anti-PF-06664178 antibodies
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 monthsPopulation: Of all enrolled 31 patients who were treated, 1 participant from the 0.60mg/kg cohort and 1 participant from the 4.20mg/kg cohort did not have post-dose tumor evaluations for they were discontinued form study prior to having disease assessment .
Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline.
Outcome measures
| Measure |
PF-06664178 0.15 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=3 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 Participants
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Number of Participants With Objective Tumor Response[Part 1]
SD
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
4 participants
|
—
|
2 participants
|
|
Overall Number of Participants With Objective Tumor Response[Part 1]
PD
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
—
|
3 participants
|
|
Overall Number of Participants With Objective Tumor Response[Part 1]
In
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
3 participants
|
|
Overall Number of Participants With Objective Tumor Response[Part 1]
Sym
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 monthsPopulation: No participant was analyzed due to study termination
Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Cmax of PF-06664178 was observed directly from data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Cmax of total antibody PF-06479118 was observed directly from data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Cmax of unconjugated payload PF-06380101 was observed directly from data
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Population: No participant was analyzed due to study termination
Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatmentPopulation: Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination
Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.
Outcome measures
Outcome data not reported
Adverse Events
PF-06664178 0.15 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06664178 0.30 mg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06664178 0.60 mg/kg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06664178 1.20 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06664178 2.40 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06664178 3.60 mg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06664178 4.20 mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-06664178 4.80 mg/kg
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Total
Serious events: 13 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-06664178 0.15 mg/kg
n=2 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=4 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
n=1 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
Total
n=31 participants at risk
Treatment Group Description TBD
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Disease progression
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Pain
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
100.0%
1/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
Other adverse events
| Measure |
PF-06664178 0.15 mg/kg
n=2 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.15 mg/kg was administered on Day 1 of each 21-day cycle per the dose administration instructions (DAI) as an intravenous (IV) infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.30 mg/kg
n=2 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.30 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 0.60 mg/kg
n=4 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 0.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 1.20 mg/kg
n=4 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 1.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 2.40 mg/kg
n=4 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 2.40 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 3.60 mg/kg
n=6 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 3.60 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.20 mg/kg
n=1 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.20 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
PF-06664178 4.80 mg/kg
n=8 participants at risk
Participants were enrolled in cohorts of 2-4 to receive PF-06664178 in an open-label, unblinded manner and treated with PF-06664178 in 7 sequential dose levels between 0.15 and 4.8 mg/kg. PF-06664178 4.80 mg/kg was administered on Day 1 of each 21-day cycle per the DAI as an IV infusion over 60 minutes ±5 minutes on an outpatient basis.
|
Total
n=31 participants at risk
Treatment Group Description TBD
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
37.5%
3/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
100.0%
1/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.9%
4/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.9%
4/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Facial wasting
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
62.5%
5/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.8%
8/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
62.5%
5/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
35.5%
11/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
19.4%
6/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
3/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
37.5%
3/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
32.3%
10/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
4/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Chills
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
3/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
4/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
29.0%
9/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Early satiety
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Face oedema
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Fatigue
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
75.0%
3/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
66.7%
4/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
4/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
41.9%
13/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Injection site erythema
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Injection site reaction
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
100.0%
1/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Local swelling
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Malaise
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
100.0%
1/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
37.5%
3/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Pain
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.9%
4/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Pneumonia
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
66.7%
4/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.8%
8/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Body temperature increased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Cardiac murmur
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Eosinophil count increased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Haematocrit decreased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
Weight decreased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
4/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.8%
8/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
37.5%
3/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.9%
4/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
75.0%
3/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
22.6%
7/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.9%
4/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.9%
4/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
22.6%
7/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
75.0%
3/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
100.0%
1/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.9%
4/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
3/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Tension headache
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
19.4%
6/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
2/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
50.0%
4/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.8%
8/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
100.0%
1/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.1%
5/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
12.5%
1/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
50.0%
1/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
33.3%
2/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
6.5%
2/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
1/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
3.2%
1/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/2 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/4 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
16.7%
1/6 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
0.00%
0/1 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
25.0%
2/8 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
9.7%
3/31 • From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(at least 28 days and no more than 35 days after discontinuation of treatment)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER