Trial Outcomes & Findings for A Study Of PF-06263507 In Patients With Advanced Solid Tumors (NCT NCT01891669)
NCT ID: NCT01891669
Last Updated: 2019-01-09
Results Overview
DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting \>7 days, 2) Febrile neutropenia, 3) Grade \>=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade \>=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Baseline up to Cycle 2 Day 1 (22 days)
Results posted on
2019-01-09
Participant Flow
Participant milestones
| Measure |
PF-06263507 0.05 mg/kg
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
2
|
6
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
2
|
2
|
2
|
2
|
1
|
2
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
0
|
0
|
0
|
1
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
PF-06263507 0.05 mg/kg
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Of PF-06263507 In Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
57 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
41 years
STANDARD_DEVIATION 22.6 • n=5 Participants
|
60 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
53.5 years
STANDARD_DEVIATION 14.8 • n=21 Participants
|
62 years
STANDARD_DEVIATION 36.8 • n=10 Participants
|
61.5 years
STANDARD_DEVIATION 7.8 • n=115 Participants
|
65.2 years
STANDARD_DEVIATION 9.9 • n=6 Participants
|
57.7 years
STANDARD_DEVIATION 5.1 • n=6 Participants
|
67.7 years
STANDARD_DEVIATION 5.9 • n=64 Participants
|
59.9 years
STANDARD_DEVIATION 12.7 • n=17 Participants
|
|
Sex: Female, Male
FEMALE
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
15 Participants
n=17 Participants
|
|
Sex: Female, Male
MALE
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
11 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Cycle 2 Day 1 (22 days)Population: All enrolled participants who received at least one dose of study medication.
DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting \>7 days, 2) Febrile neutropenia, 3) Grade \>=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade \>=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.Population: All enrolled participants who received at least one dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 1
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 2
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Grade 5
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
Any AEs, Total
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
6 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.Population: All enrolled participants who received at least one dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 1
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
4 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 2
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 4
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 5
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Any AEs, Total
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
6 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatmentPopulation: All enrolled participants who received at least one dose of study medication.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Anemia Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Anemia Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Hemoglobin increased Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Lymphopenia Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Lymphopenia Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Lymphopenia Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Lymphopenia Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Platelets Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Platelets Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
Platelets Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematological Test Abnormalities in All Cycles.
White blood cells (WBC) Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatmentPopulation: All enrolled participants who received at least one dose of study medication.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypokalemia Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypokalemia Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypomagnesemia Grade 1
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hyponatremia Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hyponatremia Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypophosphatemia Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypophosphatemia Grade3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypocalcemia Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypoglycemia Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
AST Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Alanine aminotransferase (ALT) Grade 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Alkaline phosphatase Grade 1
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Alkaline phosphatase Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Alkaline phosphatase Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Aspartate aminotransferase (AST) Grade 1
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
AST Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Bilirubin (total) Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Bilirubin (total) Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Creatinine Grade 1
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Creatinine Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypercalcemia Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypercalcemia Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hyperglycemia Grade 1
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hyperglycemia Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hyperkalemia Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypernatremia Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypoalbuminemia Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypoalbuminemia Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hypocalcemia Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatmentPopulation: All enrolled participants who received at least one dose of study medication.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormalities in Urine Protein in All Cycles.
Urine protein Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Urine Protein in All Cycles.
Urine protein Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.Population: All enrolled participants who received at least one dose of study medication.
Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of \<90 millimeters of mercury (mm Hg) or change in sitting SBP of \>=30 mm Hg, sitting diastolic blood pressure (DBP) of \<50 mm Hg or change in sitting DBP of \>=20 mm Hg, sitting pulse rate of \<40 or \>120 beats per minute (bpm).
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
SBP maximum decrease from baseline >=30 mm Hg
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
DBP maximum decrease from baseline >=20 mm Hg
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
DBP <50 mm Hg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
SBP maximum increase from baseline >=30 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
DBP maximum increase from baseline >=20 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medicationPopulation: All enrolled participants who received at least one dose of study medication.
The number of participants with positive anti-PF-06263507 antibody.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-PF-06263507 Antibody
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.Population: Participants who had received at least one dose of study medication and had a baseline tumor assessment
Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)\>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \>=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Best Overall Response (BOR)
Stable/No response
|
1 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
1 pariticpants
|
|
Number of Participants With Best Overall Response (BOR)
CR
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
|
Number of Participants With Best Overall Response (BOR)
PR
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
|
Number of Participants With Best Overall Response (BOR)
Objective progression
|
1 pariticpants
|
2 pariticpants
|
1 pariticpants
|
1 pariticpants
|
2 pariticpants
|
2 pariticpants
|
2 pariticpants
|
4 pariticpants
|
3 pariticpants
|
1 pariticpants
|
|
Number of Participants With Best Overall Response (BOR)
Symptomatic deterioration
|
0 pariticpants
|
0 pariticpants
|
1 pariticpants
|
1 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
|
Number of Participants With Best Overall Response (BOR)
Early death
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
|
Number of Participants With Best Overall Response (BOR)
Interminate
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
2 pariticpants
|
0 pariticpants
|
1 pariticpants
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.Population: Participants who had received at least one dose of study medication and had a baseline tumor assessment
Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
SECONDARY outcome
Timeframe: Baseline to deathPopulation: All enrolled participants
Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
Number of deaths
|
0 pariticpants
|
1 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
0 pariticpants
|
1 pariticpants
|
0 pariticpants
|
1 pariticpants
|
|
Overall Survival
Number for censored
|
2 pariticpants
|
1 pariticpants
|
2 pariticpants
|
2 pariticpants
|
2 pariticpants
|
2 pariticpants
|
2 pariticpants
|
5 pariticpants
|
3 pariticpants
|
2 pariticpants
|
SECONDARY outcome
Timeframe: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.Population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)
|
1.07 hour
Interval 1.03 to 1.1
|
1.00 hour
Interval 1.0 to 1.0
|
2.49 hour
Interval 0.983 to 4.0
|
1.01 hour
Interval 1.0 to 1.02
|
1.03 hour
Interval 1.02 to 1.03
|
1.02 hour
Interval 1.0 to 1.03
|
2.49 hour
Interval 1.0 to 3.98
|
1.13 hour
Interval 0.983 to 11.0
|
1.03 hour
Interval 1.0 to 1.03
|
1.22 hour
Interval 1.17 to 7.93
|
SECONDARY outcome
Timeframe: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.Population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 Participants
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)
|
1.07 hour
Interval 1.03 to 1.1
|
4.00 hour
Interval 4.0 to 4.0
|
2.53 hour
Interval 1.05 to 4.0
|
1.01 hour
Interval 1.0 to 1.02
|
6.01 hour
Interval 1.02 to 11.0
|
1.02 hour
Interval 1.0 to 1.03
|
7.44 hour
Interval 3.98 to 10.9
|
4.00 hour
Interval 1.07 to 8.08
|
8.00 hour
Interval 1.03 to 8.05
|
3.90 hour
Interval 1.17 to 4.02
|
SECONDARY outcome
Timeframe: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.Population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
PF-06263507 0.05 mg/kg
n=2 Participants
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 Participants
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 Participants
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 Participants
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 Participants
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 Participants
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=6 Participants
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=3 Participants
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 Participants
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)
|
36.2 hour
Interval 24.4 to 48.0
|
16.0 hour
Interval 8.0 to 24.0
|
37.2 hour
Interval 26.3 to 48.0
|
51.0 hour
Interval 4.0 to 98.0
|
9.99 hour
Interval 7.98 to 12.0
|
9.51 hour
Interval 8.12 to 10.9
|
8.02 hour
Interval 7.3 to 12.0
|
8.13 hour
Interval 8.05 to 70.8
|
8.25 hour
Interval 7.93 to 8.28
|
—
|
Adverse Events
PF-06263507 0.05 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06263507 0.1 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06263507 0.19 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06263507 0.37 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06263507 0.73 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06263507 1.42 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06263507 2.78 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06263507 4.34 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06263507 5.42 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-06263507 6.5 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-06263507 0.05 mg/kg
n=2 participants at risk
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 participants at risk
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 participants at risk
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 participants at risk
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 participants at risk
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 participants at risk
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 participants at risk
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 participants at risk
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 participants at risk
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 participants at risk
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
Other adverse events
| Measure |
PF-06263507 0.05 mg/kg
n=2 participants at risk
PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.1 mg/kg
n=2 participants at risk
PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.19 mg/kg
n=2 participants at risk
PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.37 mg/kg
n=2 participants at risk
PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 0.73 mg/kg
n=2 participants at risk
PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 1.42 mg/kg
n=2 participants at risk
PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 2.78 mg/kg
n=2 participants at risk
PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 4.34 mg/kg
n=6 participants at risk
PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 5.42 mg/kg
n=3 participants at risk
PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
PF-06263507 6.5 mg/kg
n=3 participants at risk
PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Waist circumference increased
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
33.3%
2/6 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
100.0%
3/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
33.3%
2/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
100.0%
3/3 • Baseline to end of treatment/withdrawal
|
|
Cardiac disorders
Tachycardia
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Corneal deposits
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Eye pain
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Eye pruritus
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Eye swelling
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Keratitis
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Keratopathy
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Lacrimation decreased
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
3/6 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Vision blurred
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
33.3%
2/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
100.0%
2/2 • Baseline to end of treatment/withdrawal
|
50.0%
3/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Application site irritation
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Chest discomfort
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Chest pain
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Chills
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Fatigue
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
66.7%
4/6 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Inflammation
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Oedema
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Oedema peripheral
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Peripheral swelling
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Infections and infestations
Oral infection
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Injury, poisoning and procedural complications
Fall
|
100.0%
2/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
66.7%
2/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Blood creatinine increased
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
33.3%
2/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Blood urea increased
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Cardiac murmur
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Troponin I increased
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
33.3%
2/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
33.3%
2/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Renal and urinary disorders
Obstructive uropathy
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
2/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
33.3%
2/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
16.7%
1/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Vascular disorders
Hot flush
|
50.0%
1/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/2 • Baseline to end of treatment/withdrawal
|
0.00%
0/6 • Baseline to end of treatment/withdrawal
|
0.00%
0/3 • Baseline to end of treatment/withdrawal
|
33.3%
1/3 • Baseline to end of treatment/withdrawal
|
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