Trial Outcomes & Findings for A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors (NCT NCT02444793)

NCT ID: NCT02444793

Last Updated: 2019-02-27

Results Overview

DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting \>7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) \<1000/mm3 with a single temperature of \>38.3 degrees C (101 degrees F) or a sustained temperature of \>=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade \>=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade \>=3 laboratory abnormalities (other than aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: First 2 Cycles (28 days in each cycle)
• Results posted on: 2019-02-27

Participant Flow

Participant milestones

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Study STARTED	11	6	4	3
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	11	6	4	3

Reasons for withdrawal

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Overall Study Lost to Follow-up	2	2	0	0
Overall Study Death	0	3	0	0
Overall Study Other	0	0	2	0
Overall Study Objective progression or relapse	9	1	2	3

Baseline Characteristics

A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	Total n=24 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 4.9 • n=5 Participants	66.2 years STANDARD_DEVIATION 8.6 • n=7 Participants	67.8 years STANDARD_DEVIATION 4.0 • n=5 Participants	62.7 years STANDARD_DEVIATION 8.7 • n=4 Participants	63.9 years STANDARD_DEVIATION 6.5 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: First 2 Cycles (28 days in each cycle)

Population: All enrolled participants who were eligible for the study and received study treatment.

DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting >7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade >=3 neutropenic infection; (4) Grade >=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade >=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade >=3 laboratory abnormalities (other than aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Dose Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to 60 days after last dose of study treatment

Population: All enrolled participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Grade 5	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) AEs	11 Participants	6 Participants	4 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) SAEs	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants With Treatment-Emergent Adverse Events (All Causalities) Grade 3 or 4	2 Participants	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 up to 60 days after last dose of study treatment

Population: All enrolled participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with PF-05082566. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) AEs	7 Participants	6 Participants	3 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) Grade 3 or 4 AEs	0 Participants	2 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) Grade 5 AEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up tp 60 days after last dose of study treatment

Population: All enrolled participants who received at least 1 dose of study treatment.

An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with Mogamulizumab. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) Grade 5 AEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) AEs	7 Participants	6 Participants	4 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) Grade 3 or 4 AEs	0 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

Population: All enrolled participants who received at least 1 dose of study treatment.

The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Anemia	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hemoglobin increased	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Lymphocyte count increased	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Lymphopenia	6 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Neutrophils (absolute)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Platelets	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 White blood cells	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

Population: All enrolled participants who received at least 1 dose of study treatment.

The chemistry laboratory tests included: Alanine aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Lactate Dehydrogenase, Sodium, Potassium, Magnesium, Total Calcium, Phosphorus or Phosphate, Total bilirubin, Creatinine or creatinine clearance, Albumin, Total proteins, Uric Acid, BUN or Urea, Immunoglobulin G, Glucose (fasted).

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 AST	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Creatinine	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hyperglycemia	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypokalemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypomagnesemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 ALT	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Alkaline phosphatase	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Bilirubin (total)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypercalcemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hyperkalemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypermagnesemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypernatremia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypoalbuminemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypocalcemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypoglycemia	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hyponatremia	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 Hypophosphatemia	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

Population: All enrolled participants who received at least 1 dose of study treatment.

Blood pressure (BP) and pulse rate were recorded in supine or sitting position.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Clinical Significant Observations in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 2 Day 1; End of the treatment.

Population: All enrolled participants who received at least 1 dose of study treatment. Number analyzed was the number of participants at the given category.

Physical examination included an examination of major body systems, including general, head, ears, eyes, nose, mouth, throat, neck, lungs, heart, abdomen, musculoskeletal, lymph nodes, neurological and external genitalia. Significant changes from baseline were reported in each category.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Significant Changes From Baseline in Physical Examination Cycle 2 Day 1	1 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Significant Changes From Baseline in Physical Examination End of Treatment	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment

Population: All enrolled participants who received at least 1 dose of study treatment.

ECOG performance status was classified as 5 grades: 0 (Fully active, able to carry on all predisease performance without restriction); 1 (Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work); 2 (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self care. Totally confined to bed or chair); 5 (Death). On-study shifts to ECOG performance statuses of 2, 3, 4 or 5 were reported.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Maximum Observed Serum Concentration (Cmax) was observed directly from the data.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5	18.71 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	27.80 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	105.7 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Dose normalized Cmax was calculated by Cmax / Dose

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Dose Normalized Cmax of PF-05082566-Cycle 5	15.61 µg/mL/mg/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	25.60 µg/mL/mg/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	21.13 µg/mL/mg/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Maximum Observed Serum Concentration (Cmax) was observed directly from the data.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=5 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Cmax of Mogamulizumab-Cycles 1 and 5 Cycle 5	31.05 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	31.90 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	32.62 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values
Cmax of Mogamulizumab-Cycles 1 and 5 Cycle 1	18.78 μg/mL Geometric Coefficient of Variation 19	19.73 μg/mL Geometric Coefficient of Variation 32	19.77 μg/mL Geometric Coefficient of Variation 16	19.82 μg/mL Geometric Coefficient of Variation 19

SECONDARY outcome

Timeframe: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5	1.300 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	1.160 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	3.464 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Ctrough of Mogamulizumab- Cycle 5	15.45 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	9.040 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	15.99 μg/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Time for Cmax (Tmax) was observed directly from the data.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Time for Cmax (Tmax) of PF-05082566-Cycle 5	2.02 hour Interval 2.0 to 2.03	6.00 hour Interval 6.0 to 6.0	—	1.08 hour Interval 1.0 to 1.25

SECONDARY outcome

Timeframe: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Time of last measurable concentration was observed directly from data.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5	336 hour Interval 335.0 to 336.0	309 hour Interval 309.0 to 309.0	—	97.6 hour Interval 25.1 to 170.0

SECONDARY outcome

Timeframe: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Time for Cmax (Tmax) was observed directly from the data.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=5 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Tmax of Mogamulizumab-Cycles 1 and 5 Cycle 1	1.28 hour Interval 1.0 to 5.5	1.30 hour Interval 1.1 to 2.25	1.24 hour Interval 1.15 to 4.58	1.03 hour Interval 0.917 to 1.18
Tmax of Mogamulizumab-Cycles 1 and 5 Cycle 5	13.5 hour Interval 4.52 to 22.4	1.05 hour Interval 1.05 to 1.05	—	1.05 hour Interval 1.02 to 1.07

SECONDARY outcome

Timeframe: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Time of last measurable concentration was observed directly from the data.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=5 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Tlast of Mogamulizumab-Cycles 1 and 5 Cycle 1	166 hour Interval 164.0 to 285.0	166 hour Interval 163.0 to 214.0	143 hour Interval 22.4 to 194.0	166 hour Interval 166.0 to 171.0
Tlast of Mogamulizumab-Cycles 1 and 5 Cycle 5	335 hour Interval 334.0 to 335.0	308 hour Interval 308.0 to 308.0	—	107 hour Interval 45.2 to 168.0

SECONDARY outcome

Timeframe: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5	1143 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	2700 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	3875 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Dose normalized AUClast was calculated by AUClast / Dose

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Dose Normalized AUClast of PF-05082566-Cycle 5	952.5 µg•hr/mL/mg/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	2490 µg•hr/mL/mg/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	773.0 µg•hr/mL/mg/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=5 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
AUClast of Mogamulizumab-Cycles 1 and 5 Cycle 1	2001 μg*hr/mL Geometric Coefficient of Variation 24	2182 μg*hr/mL Geometric Coefficient of Variation 36	1382 μg*hr/mL Geometric Coefficient of Variation 133	2126 μg*hr/mL Geometric Coefficient of Variation 24
AUClast of Mogamulizumab-Cycles 1 and 5 Cycle 5	6853 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	5870 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	2310 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

AUC168 was area under the serum concentration-time profile from time 0 to 168 hours post dose (Cycle 1 only where dosing was once a week), which was measured by Linear/Log trapezoidal method.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=5 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1	1945 μg*hr/mL Geometric Coefficient of Variation 25	2124 μg*hr/mL Geometric Coefficient of Variation 33	2353 μg*hr/mL Geometric Coefficient of Variation 14	2123 μg*hr/mL Geometric Coefficient of Variation 24

SECONDARY outcome

Timeframe: Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5	6868 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	6160 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	6950 μg*hr/mL Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15

Population: The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.

Clearance (CL) was measured by Dose / AUCtau

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Clearance (CL) of Mogamulizumab-Cycle 5	0.146 mL/hr/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	0.162 mL/hr/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values	—	0.144 mL/hr/kg Geometric Coefficient of Variation NA fewer than 3 participants had reportable parameter values

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

Population: Number of participants analyzed was determined as participants with treatment-induced ADA.

Serum samples were assayed for ADA using a validated analytical method.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=7 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Anti-Drug Antibody (ADA) Titer for PF-05082566	14.98 Titer Interval 12.31 to 16.31	10.80 Titer Interval 6.23 to 10.92	17.25 Titer Only 1 participant was positive for ADA	8.03 Titer Interval 6.23 to 9.82

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

Population: Number of participants analyzed was determined as participants with treatment-induced NAb.

ADA positive samples were further analyzed for NAb using a validated assay.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=7 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=2 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Neutralizing Antibodies (NAb) Titers for PF-05082566	1.80 Titer Interval 1.56 to 1.86	1.30 Titer Interval 1.3 to 1.3	2.64 Titer Only 1 participant was positive for NAb	1.30 Titer Only 1 participant was positive for NAb

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

Population: Number of participants analyzed was determined as participants with treatment-induced ADA.

Serum samples were assayed for ADA using a validated analytical method.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=1 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Anti-Drug Antibody (ADA) Titers for Mogamulizumab	—	1024 Titer Only 1 participant was positive for ADA	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months

Population: Number of participants analyzed was determined as participants with treatment-induced NAb.

ADA positive samples were further analyzed for NAb using a validated assay

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 8 weeks up to 24 months

Population: The full analysis set included all enrolled participants.

OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Immune-related OR (irOR) was defined as immune-related BOR (irBOR) of immune-related CR (irCR) and immune-related PR (irPR) according to immune-related RECIST. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

Outcome measures

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 Participants PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) immune-related Objective Response	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) Objective Response	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Every 8 weeks up to 24 months

Population: No participants were enrolled in the dose-expansion portion.

TTR was defined, for participants with an OR, as the time from the date of first dose of study treatment to the first documentation of OR (CR or PR), which was subsequently confirmed. irTTR was defined, for participants with an irOR, as the time from the first dose of study treatment to the first documentation of irOR (irCR or irPR) which was subsequently confirmed. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months

Population: No participants were enrolled in the dose-expansion portion.

DR was defined, for participants with an OR, as the time from first documentation of OR (CR or PR) to the date of first documentation of objective progression disease (PD) or death due to any cause. irDR was defined, for participants with an irOR, as the time from the first documentation of irOR (irCR or irPR) to the date of first documentation of immune-related PD (irPD) (which was subsequently confirmed) or death due to any cause. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 8 weeks up to 24 months

Population: No participants were enrolled in the dose-expansion portion.

PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. irPFS was defined as the time from the first dose of study treatment to the date of first documentation of irPD (which was subsequently confirmed) or death due to any cause, whichever occurred first. PD:20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.

Outcome measures

Outcome data not reported

Adverse Events

PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

PF-05082566 100 mg + Mogamulizumab 1 mg/kg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 3 deaths

PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Disease progression	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Pyrexia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Clostridium difficile colitis	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Pneumonia	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Salmonellosis	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Sepsis	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Vascular disorders Embolism	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Vascular disorders Haemorrhage	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment

Other adverse events

Measure	PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg n=11 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 100 mg + Mogamulizumab 1 mg/kg n=6 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg n=4 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.	PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg n=3 participants at risk PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg.
Blood and lymphatic system disorders Anaemia	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	50.0% 3/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Cardiac disorders Pericardial effusion	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Cardiac disorders Tachycardia	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Eye disorders Erythema of eyelid	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Eye disorders Vision blurred	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Abdominal pain lower	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Constipation	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	66.7% 2/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Diarrhoea	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	50.0% 3/6 • Day 1 up to 60 days after last dose of study treatment	50.0% 2/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Dry mouth	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Nausea	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	50.0% 2/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Stomatitis	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Gastrointestinal disorders Vomiting	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Chest pain	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Chills	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Face oedema	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Fatigue	18.2% 2/11 • Day 1 up to 60 days after last dose of study treatment	83.3% 5/6 • Day 1 up to 60 days after last dose of study treatment	50.0% 2/4 • Day 1 up to 60 days after last dose of study treatment	66.7% 2/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Malaise	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Oedema peripheral	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Pyrexia	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	33.3% 2/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
General disorders Temperature intolerance	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Immune system disorders Hypersensitivity	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Genital herpes	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Otitis media	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Pneumonia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Respiratory tract infection	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Upper respiratory tract infection	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	33.3% 2/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Urinary tract infection	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Infections and infestations Viral upper respiratory tract infection	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Injury, poisoning and procedural complications Contusion	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Injury, poisoning and procedural complications Infusion related reaction	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Investigations Activated partial thromboplastin time prolonged	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Investigations Blood alkaline phosphatase increased	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Investigations Blood creatinine increased	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Investigations Lymphocyte count decreased	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Investigations Weight decreased	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Decreased appetite	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	33.3% 2/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Hypophosphataemia	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Malnutrition	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Nervous system disorders Dysgeusia	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Nervous system disorders Headache	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Nervous system disorders Peripheral sensory neuropathy	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Nervous system disorders Syncope	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Psychiatric disorders Abnormal dreams	27.3% 3/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Psychiatric disorders Insomnia	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Renal and urinary disorders Proteinuria	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	33.3% 2/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Nasal oedema	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	18.2% 2/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Dry skin	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Erythema	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Papule	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	33.3% 2/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Rash	45.5% 5/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	66.7% 2/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Rash erythematous	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	16.7% 1/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Vascular disorders Hypertension	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	33.3% 1/3 • Day 1 up to 60 days after last dose of study treatment
Vascular disorders Hypotension	0.00% 0/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	25.0% 1/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment
Vascular disorders Orthostatic hypotension	9.1% 1/11 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/6 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/4 • Day 1 up to 60 days after last dose of study treatment	0.00% 0/3 • Day 1 up to 60 days after last dose of study treatment

Additional Information

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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