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A Study Of PF-06263507 In Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01891669
Recruitment Status : Terminated (The study was terminated on June 23, 2015 due to the company's change in prioritization for the portfolio and is not due to any safety concerns.)
First Posted : July 3, 2013
Results First Posted : June 24, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplasms
Carcinoma, Non Small Cell Lung
Breast Neoplasms
Ovarian Neoplasms
Intervention Drug: PF-06263507
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description 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 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 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 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 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 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 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 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 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 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.
Period Title: Overall Study
Started 2 2 2 2 2 2 2 6 3 3
Completed 0 1 2 2 2 2 1 2 2 1
Not Completed 2 1 0 0 0 0 1 4 1 2
Reason Not Completed
Death             0             0             0             0             0             0             0             1             0             1
Withdrawal by Subject             1             1             0             0             0             0             1             2             1             1
Other             1             0             0             0             0             0             0             1             0             0
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg Total
Hide Arm/Group Description 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 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 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 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 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 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 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 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 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 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 of all reporting groups
Overall Number of Baseline Participants 2 2 2 2 2 2 2 6 3 3 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 2 participants 2 participants 2 participants 2 participants 2 participants 6 participants 3 participants 3 participants 26 participants
60.5  (2.1) 57  (4.2) 41  (22.6) 60  (7.1) 53.5  (14.8) 62  (36.8) 61.5  (7.8) 65.2  (9.9) 57.7  (5.1) 67.7  (5.9) 59.9  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 2 participants 2 participants 2 participants 2 participants 6 participants 3 participants 3 participants 26 participants
FEMALE
1
  50.0%
1
  50.0%
1
  50.0%
0
   0.0%
1
  50.0%
2
 100.0%
2
 100.0%
4
  66.7%
2
  66.7%
1
  33.3%
15
  57.7%
MALE
1
  50.0%
1
  50.0%
1
  50.0%
2
 100.0%
1
  50.0%
0
   0.0%
0
   0.0%
2
  33.3%
1
  33.3%
2
  66.7%
11
  42.3%
1.Primary Outcome
Title Number of Participants With Dose-limiting Toxicities (DLT)
Hide Description 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.
Time Frame Baseline up to Cycle 2 Day 1 (22 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 1 0 2
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: participants
Any AEs, Grade 1 1 0 1 2 0 2 1 0 0 0
Any AEs, Grade 2 1 1 1 0 2 0 0 2 2 1
Any AEs, Grade 3 0 1 0 0 0 0 0 3 1 2
Any AEs, Grade 4 0 0 0 0 0 0 1 0 0 0
Any AEs, Grade 5 0 0 0 0 0 0 0 1 0 0
Any AEs, Total 2 2 2 2 2 2 2 6 3 3
3.Secondary Outcome
Title Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
Hide Description 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.
Time Frame Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: participants
Any AEs, Grade 1 1 1 1 2 1 2 2 4 1 0
Any AEs, Grade 2 0 0 0 0 0 0 0 1 1 2
Any AEs, Grade 3 0 0 0 0 0 0 0 1 1 1
Any AEs, Grade 4 0 0 0 0 0 0 0 0 0 0
Any AEs, Grade 5 0 0 0 0 0 0 0 0 0 0
Any AEs, Total 1 1 1 2 1 2 2 6 3 3
4.Secondary Outcome
Title Number of Participants With Hematological Test Abnormalities in All Cycles.
Hide Description Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.
Time Frame Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: Participants
Anemia Grade 1 1 0 1 2 1 2 0 4 1 2
Anemia Grade 2 0 0 1 0 0 0 1 1 2 1
Hemoglobin increased Grade 1 0 0 0 0 0 0 0 1 0 0
Lymphopenia Grade 1 0 0 1 1 0 2 0 0 2 2
Lymphopenia Grade 2 0 0 0 1 1 0 1 3 0 0
Lymphopenia Grade 3 1 0 0 0 1 0 0 1 0 0
Lymphopenia Grade 4 1 0 0 0 0 0 0 1 0 0
Platelets Grade 1 0 0 0 1 1 0 0 3 1 0
Platelets Grade 2 0 0 0 0 0 0 0 2 0 2
Platelets Grade 3 0 0 0 0 0 0 0 0 0 1
White blood cells (WBC) Grade 1 0 0 0 0 1 0 0 1 0 0
5.Secondary Outcome
Title Number of Participants With Chemistry Test Abnormalities in All Cycles.
Hide Description Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.
Time Frame Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: Participants
Alanine aminotransferase (ALT) Grade 1 0 0 2 0 0 1 1 1 2 1
Alkaline phosphatase Grade 1 0 1 2 1 0 0 1 3 1 1
Alkaline phosphatase Grade 2 1 0 0 0 0 0 0 1 0 2
Alkaline phosphatase Grade 3 0 0 0 0 0 0 0 0 1 0
Aspartate aminotransferase (AST) Grade 1 1 1 2 0 1 1 2 4 0 1
AST Grade 2 0 0 0 0 0 0 0 1 1 2
AST Grade 3 0 0 0 0 0 0 0 0 2 0
Bilirubin (total) Grade 1 0 0 0 0 0 0 0 1 0 0
Bilirubin (total) Grade 2 0 0 0 0 0 0 0 0 1 0
Creatinine Grade 1 0 2 2 2 2 2 2 6 2 1
Creatinine Grade 2 1 0 0 0 0 0 0 0 0 1
Hypercalcemia Grade 1 0 0 0 0 0 0 0 0 1 0
Hypercalcemia Grade 4 0 0 0 0 0 0 1 0 0 0
Hyperglycemia Grade 1 1 1 2 1 2 2 2 5 1 1
Hyperglycemia Grade 2 1 1 0 1 0 0 0 1 0 2
Hyperkalemia Grade 1 0 0 0 0 0 0 0 2 0 0
Hypernatremia Grade 1 0 0 1 0 0 0 0 0 0 0
Hypoalbuminemia Grade 1 0 1 1 1 1 2 1 2 0 1
Hypoalbuminemia Grade 2 1 1 0 0 0 0 1 1 3 2
Hypocalcemia Grade 1 0 1 0 0 0 0 0 2 0 1
Hypocalcemia Grade 2 0 0 0 0 0 0 0 0 0 1
Hypoglycemia Grade 1 0 0 0 0 0 1 0 0 0 0
Hypokalemia Grade 1 1 1 0 0 0 1 2 3 1 0
Hypokalemia Grade 3 0 0 0 0 0 0 0 0 0 1
Hypomagnesemia Grade 1 0 1 2 0 0 0 2 1 3 1
Hyponatremia Grade 1 1 1 0 0 0 0 1 5 3 2
Hyponatremia Grade 3 0 1 0 0 0 0 0 0 0 1
Hypophosphatemia Grade 2 1 1 0 0 1 0 1 0 0 2
Hypophosphatemia Grade3 0 0 0 1 0 0 0 1 0 0
6.Secondary Outcome
Title Number of Participants With Abnormalities in Urine Protein in All Cycles.
Hide Description Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.
Time Frame Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: Participants
Urine protein Grade 1 1 0 1 0 0 0 0 0 0 0
Urine protein Grade 2 0 0 0 0 0 0 0 0 0 1
7.Secondary Outcome
Title Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: Participants
DBP <50 mm Hg 0 0 1 0 1 0 0 0 0 0
SBP maximum increase from baseline >=30 mm Hg 0 0 0 1 0 2 0 0 1 0
DBP maximum increase from baseline >=20 mm Hg 0 0 0 0 1 1 0 0 1 1
SBP maximum decrease from baseline >=30 mm Hg 1 0 1 0 0 0 2 2 0 1
DBP maximum decrease from baseline >=20 mm Hg 1 0 2 0 1 0 0 3 0 0
8.Secondary Outcome
Title Number of Participants With Positive Anti-PF-06263507 Antibody
Hide Description The number of participants with positive anti-PF-06263507 antibody.
Time Frame Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study medication.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: Participants
1 0 1 1 0 0 0 0 0 1
9.Secondary Outcome
Title Number of Participants With Best Overall Response (BOR)
Hide Description 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.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had received at least one dose of study medication and had a baseline tumor assessment
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: pariticpants
CR 0 0 0 0 0 0 0 0 0 0
PR 0 0 0 0 0 0 0 0 0 0
Stable/No response 1 0 0 0 0 0 0 0 0 1
Objective progression 1 2 1 1 2 2 2 4 3 1
Symptomatic deterioration 0 0 1 1 0 0 0 0 0 0
Early death 0 0 0 0 0 0 0 0 0 0
Interminate 0 0 0 0 0 0 0 2 0 1
10.Secondary Outcome
Title Objective Response
Hide Description 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.
Time Frame Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had received at least one dose of study medication and had a baseline tumor assessment
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: pariticpants
0 0 0 0 0 0 0 0 0 0
11.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.
Time Frame Baseline to death
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Measure Type: Number
Unit of Measure: pariticpants
Number of deaths 0 1 0 0 0 0 0 1 0 1
Number for censored 2 1 2 2 2 2 2 5 3 2
12.Secondary Outcome
Title Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Median (Full Range)
Unit of Measure: hour
1.07
(1.03 to 1.10)
1.00
(1.00 to 1.00)
2.49
(0.983 to 4.00)
1.01
(1.00 to 1.02)
1.03
(1.02 to 1.03)
1.02
(1.00 to 1.03)
2.49
(1.00 to 3.98)
1.13
(0.983 to 11.0)
1.03
(1.00 to 1.03)
1.22
(1.17 to 7.93)
13.Secondary Outcome
Title Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 2 6 3 3
Median (Full Range)
Unit of Measure: hour
1.07
(1.03 to 1.10)
4.00
(4.00 to 4.00)
2.53
(1.05 to 4.00)
1.01
(1.00 to 1.02)
6.01
(1.02 to 11.0)
1.02
(1.00 to 1.03)
7.44
(3.98 to 10.9)
4.00
(1.07 to 8.08)
8.00
(1.03 to 8.05)
3.90
(1.17 to 4.02)
14.Secondary Outcome
Title Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
Arm/Group Title PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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 Number of Participants Analyzed 2 2 2 2 2 2 6 3 3
Median (Full Range)
Unit of Measure: hour
36.2
(24.4 to 48.0)
16.0
(8.00 to 24.0)
37.2
(26.3 to 48.0)
51.0
(4.00 to 98.0)
9.99
(7.98 to 12.0)
9.51
(8.12 to 10.9)
8.02
(7.30 to 12.0)
8.13
(8.05 to 70.8)
8.25
(7.93 to 8.28)
Time Frame Baseline to end of treatment/withdrawal
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Hide Arm/Group Description 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 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 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 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 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 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 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 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 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 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.
All-Cause Mortality
PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   1/6 (16.67%)   0/3 (0.00%)   0/3 (0.00%) 
Cardiac disorders                     
Atrial fibrillation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Chronic obstructive pulmonary disease * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-06263507 0.05 mg/kg PF-06263507 0.1 mg/kg PF-06263507 0.19 mg/kg PF-06263507 0.37 mg/kg PF-06263507 0.73 mg/kg PF-06263507 1.42 mg/kg PF-06263507 2.78 mg/kg PF-06263507 4.34 mg/kg PF-06263507 5.42 mg/kg PF-06263507 6.5 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   6/6 (100.00%)   3/3 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders                     
Anaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Coagulopathy * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Leukopenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Lymphadenopathy * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Thrombocytopenia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/6 (33.33%)  1/3 (33.33%)  3/3 (100.00%) 
Cardiac disorders                     
Tachycardia * 1  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Eye disorders                     
Corneal deposits * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Dry eye * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/6 (16.67%)  2/3 (66.67%)  2/3 (66.67%) 
Eye pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  2/3 (66.67%)  1/3 (33.33%) 
Eye pruritus * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Eye swelling * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Keratitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Keratopathy * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Lacrimation decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Lacrimation increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Photophobia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  3/6 (50.00%)  2/3 (66.67%)  2/3 (66.67%) 
Vision blurred * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%) 
Vitreous floaters * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders                     
Abdominal distension * 1  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  2/3 (66.67%) 
Abdominal pain * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Abdominal pain upper * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Ascites * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  1/3 (33.33%) 
Constipation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Diarrhoea * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Dry mouth * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Dyspepsia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Mouth ulceration * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Nausea * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  2/2 (100.00%)  3/6 (50.00%)  0/3 (0.00%)  1/3 (33.33%) 
Oral mucosal erythema * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Retching * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Stomatitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Vomiting * 1  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
General disorders                     
Application site irritation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Chest discomfort * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Chest pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Chills * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  2/3 (66.67%)  1/3 (33.33%) 
Fatigue * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%)  4/6 (66.67%)  2/3 (66.67%)  1/3 (33.33%) 
Inflammation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Non-cardiac chest pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Oedema * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Oedema peripheral * 1  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  1/3 (33.33%) 
Peripheral swelling * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pyrexia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Hepatobiliary disorders                     
Hepatobiliary disease * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Infections and infestations                     
Conjunctivitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Device related infection * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Fungal skin infection * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Oral infection * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Sinusitis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Upper respiratory tract infection * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Urinary tract infection * 1  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications                     
Fall * 1  2/2 (100.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Investigations                     
Alanine aminotransferase increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  1/3 (33.33%) 
Aspartate aminotransferase increased * 1  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  2/3 (66.67%)  2/3 (66.67%) 
Blood alkaline phosphatase increased * 1  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Blood bilirubin increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Blood creatinine increased * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Blood lactate dehydrogenase increased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Blood urea increased * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Cardiac murmur * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Ejection fraction decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Troponin I increased * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Urine analysis abnormal * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Waist circumference increased * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Weight decreased * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Metabolism and nutrition disorders                     
Decreased appetite * 1  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  2/6 (33.33%)  2/3 (66.67%)  1/3 (33.33%) 
Dehydration * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Hypercalcaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hypoalbuminaemia * 1  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hypoglycaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hypokalaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Hypomagnesaemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  3/3 (100.00%)  0/3 (0.00%) 
Hyponatraemia * 1  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Hypophosphataemia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Back pain * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Flank pain * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Muscular weakness * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Musculoskeletal chest pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Neck pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Pain in extremity * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Pain in jaw * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Tumour pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Nervous system disorders                     
Dizziness * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Dysaesthesia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Dysgeusia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Headache * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  2/6 (33.33%)  1/3 (33.33%)  0/3 (0.00%) 
Lethargy * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Neuropathy peripheral * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Peripheral sensory neuropathy * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Restless legs syndrome * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Psychiatric disorders                     
Agitation * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Anxiety * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Confusional state * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Insomnia * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Renal and urinary disorders                     
Haematuria * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Obstructive uropathy * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pollakiuria * 1  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Cough * 1  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  1/3 (33.33%)  0/3 (0.00%) 
Dysphonia * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Dyspnoea * 1  2/2 (100.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%) 
Dyspnoea exertional * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Epistaxis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  1/3 (33.33%) 
Haemoptysis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hiccups * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Nasal congestion * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Oropharyngeal pain * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Productive cough * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Sputum discoloured * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Wheezing * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders                     
Decubitus ulcer * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Dry skin * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
Night sweats * 1  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Onycholysis * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Pruritus * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Vascular disorders                     
Embolism * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%) 
Flushing * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%) 
Hot flush * 1  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Hypotension * 1  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
This study was terminated prematurely before treatment in Part 2 started due to a business-related decision.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 18007181021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01891669     History of Changes
Other Study ID Numbers: B4481001
First Submitted: June 10, 2013
First Posted: July 3, 2013
Results First Submitted: May 17, 2016
Results First Posted: June 24, 2016
Last Update Posted: January 9, 2019