Trial Outcomes & Findings for A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia (NCT NCT02954653)

NCT ID: NCT02954653

Last Updated: 2019-11-21

Results Overview

DLTs were classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and were defined as any of a predefined set of unacceptable hematologic and non-hematologic adverse events (AEs) occurring in the first treatment cycle unless clearly determined unrelated to PF-06747143. In addition, clinically important or persistent toxicities that were not included in the pre-specified criteria could be considered a DLT following review by the investigators and sponsor.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 8 participants
• Primary outcome timeframe: Day 1 to Day 28 of Cycle 1
• Results posted on: 2019-11-21

Participant Flow

Due to early termination of the study, the planned higher PF-06747143 dose levels (3, 10, 15, and 20 milligrams per kilogram [mg/kg]) in Part 1 were not tested; Part 2 was not conducted.

Participant milestones

Measure	Part 1: PF-06747143 0.3 mg/kg PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 3 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 3 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 10 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 15 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 15 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 20 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 20 mg/kg in 28-day cycles.	Part 2: PF-06747143 at MTD/RP2D This arm was not initiated due to early termination of the study. PF-06747143 at Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) as an intravenous infusion once weekly in 28-day cycles was optional for Part 2 and planned to be initiated in Part 2 based on single agent PF-06747143 clinical benefit in Part 1.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Overall Study STARTED	4	4	0	0	0	0	0	0	0
Overall Study Received Treatment	3	4	0	0	0	0	0	0	0
Overall Study COMPLETED	0	1	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	3	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Part 1: PF-06747143 0.3 mg/kg PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 3 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 3 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 10 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 15 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 15 mg/kg in 28-day cycles.	Part 1: PF-06747143 at 20 mg/kg This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 20 mg/kg in 28-day cycles.	Part 2: PF-06747143 at MTD/RP2D This arm was not initiated due to early termination of the study. PF-06747143 at Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D) as an intravenous infusion once weekly in 28-day cycles was optional for Part 2 and planned to be initiated in Part 2 based on single agent PF-06747143 clinical benefit in Part 1.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Overall Study Death	3	1	0	0	0	0	0	0	0
Overall Study Randomized but did not receive treatment	1	0	0	0	0	0	0	0	0
Overall Study Started another anti-cancer therapy	0	1	0	0	0	0	0	0	0
Overall Study Treatment failure and consent withdrawal	0	1	0	0	0	0	0	0	0

Baseline Characteristics

A Study Of PF-06747143, As Single Agent Or In Combination With Standard Chemotherapy In Adult Patients With Acute Myeloid Leukemia

Baseline characteristics by cohort

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Total n=7 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 4 • n=5 Participants	63.8 years STANDARD_DEVIATION 14.4 • n=7 Participants	64.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Age, Customized 18-44 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 45-64 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized Greater than or equal to (>=) 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 28 of Cycle 1

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

DLTs were classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and were defined as any of a predefined set of unacceptable hematologic and non-hematologic adverse events (AEs) occurring in the first treatment cycle unless clearly determined unrelated to PF-06747143. In addition, clinically important or persistent toxicities that were not included in the pre-specified criteria could be considered a DLT following review by the investigators and sponsor.

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Number of Participants With Dose-Limiting Toxicities (DLTs) [Part 1]	0 Participants	1 Participants	—	—	—

PRIMARY outcome

Timeframe: 1 year

Population: No data to report as Part 2 was not conducted.

An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: No data to report as Part 2 was not conducted.

Following parameters were to be analyzed for laboratory examination: hematology (hemoglobin, platelets, white blood cell [WBC], absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, percent blast cells); chemistry (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose [non-fasted], albumin, phosphorous or phosphate); coagulation (prothrombin time [PT] or international normalized ratio [INR], partial thromboplastin time [PTT] or activated PTT [aPTT]); urinalysis (urine dipstick for urine protein: if positive collect 24 hours and microscopic [reflex testing]; urine dipstick for urine blood: if positive collect a microscopic [reflex testing]); pregnancy test (for female participants of childbearing potential, serum or urine).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Population: Part 2 was not conducted.

Objective Response was defined as morphologic leukemia-free state (MLFS), complete remission (CR), cytogenetic CR (CRc), molecular CR (CRm), partial remission (PR), or CR or PR with incomplete blood count recovery (CRi or PRi).

MLFS: Bone marrow (BM) blasts <5%; absence of blasts with Auer rods and extramedullary disease (EMD).

CR: MLFS criteria; absolute neutrophil count (ANC)>1000/ul and platelet >100,000/ul; independence from red cell transfusions.

CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.

CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Population: Part 2 was not conducted.

Duration of ORR is the time from first documentation of MLFS, CR, CRc, CRm, PR, CRi or PRi to date of first documentation of disease progression or death due to any cause.

MLFS: BM blasts <5%; absence of blasts with Auer rods and EMD. CR: MLFS criteria; ANC>1000/ul and platelet >100,000/ul; independence from red cell transfusions.

CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.

CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

Disease progression/relapse: BM blast ≥5%; or reappearance of blast in the blood; or development of EMD.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Population: Part 2 was not conducted.

Progression/relapse free survival is the time from the start of study treatment to first documentation of disease progression or to death due to any cause, whichever occurrs first. Disease progression/relapse: Bone marrow blast ≥ 5%; or reappearance of blast in the blood; or development of extramedullary disease (EMD).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs included non-serious AEs and SAEs. Causality to study treatment was determined by the investigator.

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Part 1] AE (all causality)	3 Participants	4 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Part 1] AE (treatment related)	3 Participants	3 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Part 1] SAE (all causality)	1 Participants	3 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Part 1] SAE (treatment related)	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 year

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. 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	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Grade 2	1 Participants	0 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Grade 4	1 Participants	3 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Grade 5	1 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 year

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

Hematology laboratory abnormalities included anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophil count decreased, platelet count decreased, and white blood cell (WBC) decreased. Each laboratory parameter was graded per NCI CTCAE version 4.03.

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hemoglobin increased · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hemoglobin increased · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hemoglobin increased · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Anemia · Grade 0	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Anemia · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Anemia · Grade 2	0 Participants	1 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Anemia · Grade 3	3 Participants	3 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Anemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hemoglobin increased · Grade 0	3 Participants	4 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hemoglobin increased · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphocyte count increased · Grade 0	0 Participants	4 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphocyte count increased · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphocyte count increased · Grade 2	3 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphocyte count increased · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphocyte count increased · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphopenia · Grade 0	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphopenia · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphopenia · Grade 2	0 Participants	1 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphopenia · Grade 3	0 Participants	1 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Lymphopenia · Grade 4	3 Participants	2 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Neutrophil count decreased · Grade 0	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Neutrophil count decreased · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Neutrophil count decreased · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Neutrophil count decreased · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Neutrophil count decreased · Grade 4	3 Participants	4 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Platelet count decreased · Grade 0	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Platelet count decreased · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Platelet count decreased · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Platelet count decreased · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Platelet count decreased · Grade 4	3 Participants	4 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] WBC decreased · Grade 0	1 Participants	0 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] WBC decreased · Grade 1	0 Participants	1 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] WBC decreased · Grade 2	0 Participants	1 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] WBC decreased · Grade 3	1 Participants	1 Participants	—	—	—
Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] WBC decreased · Grade 4	1 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 year

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

Chemistry laboratory abnormalities included alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Each laboratory parameter was graded per NCI CTCAE version 4.03.

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Creatinine · Grade 1	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypermagnesemia · Grade 0	2 Participants	4 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypermagnesemia · Grade 1	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypermagnesemia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypernatremia · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoalbuminemia · Grade 1	0 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypocalcemia · Grade 3	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoglycemia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoglycemia · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoglycemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypokalemia · Grade 1	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypomagnesemia · Grade 1	2 Participants	3 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypomagnesemia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyponatremia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypophosphatemia · Grade 0	2 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] ALT · Grade 0	0 Participants	3 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] ALT · Grade 1	3 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] ALT · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] ALT · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] ALT · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Alkaline phosphatase · Grade 0	0 Participants	4 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Alkaline phosphatase · Grade 1	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Alkaline phosphatase · Grade 2	2 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Alkaline phosphatase · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Alkaline phosphatase · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] AST · Grade 0	0 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] AST · Grade 1	2 Participants	3 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] AST · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] AST · Grade 3	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] AST · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Bilirubin (total) · Grade 0	1 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Bilirubin (total) · Grade 1	0 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Bilirubin (total) · Grade 2	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Bilirubin (total) · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Bilirubin (total) · Grade 4	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Creatinine · Grade 0	1 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Creatinine · Grade 2	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Creatinine · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Creatinine · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypercalcemia · Grade 0	3 Participants	4 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypercalcemia · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypercalcemia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypercalcemia · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypercalcemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperglycemia · Grade 0	0 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperglycemia · Grade 1	1 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperglycemia · Grade 2	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperglycemia · Grade 3	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperglycemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperkalemia · Grade 0	2 Participants	3 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperkalemia · Grade 1	0 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperkalemia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperkalemia · Grade 3	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyperkalemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypermagnesemia · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypermagnesemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypernatremia · Grade 0	3 Participants	4 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypernatremia · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypernatremia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypernatremia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoalbuminemia · Grade 0	0 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoalbuminemia · Grade 2	2 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoalbuminemia · Grade 3	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoalbuminemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypocalcemia · Grade 0	0 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypocalcemia · Grade 1	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypocalcemia · Grade 2	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypocalcemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoglycemia · Grade 0	3 Participants	4 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypoglycemia · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypokalemia · Grade 0	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypokalemia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypokalemia · Grade 3	1 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypokalemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypomagnesemia · Grade 0	1 Participants	1 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypomagnesemia · Grade 3	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypomagnesemia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyponatremia · Grade 0	0 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyponatremia · Grade 1	2 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyponatremia · Grade 3	1 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hyponatremia · Grade 4	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypophosphatemia · Grade 1	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypophosphatemia · Grade 2	0 Participants	0 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypophosphatemia · Grade 3	1 Participants	2 Participants	—	—	—
Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1] Hypophosphatemia · Grade 4	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: All enrolled participants who received at least 1 dose of study treatment and had a baseline disease assessment.

Objective Response was defined as morphologic leukemia-free state (MLFS), complete remission (CR), cytogenetic CR (CRc), molecular CR (CRm), partial remission (PR), or CR or PR with incomplete blood count recovery (CRi or PRi).

MLFS: Bone marrow (BM) blasts <5%; absence of blasts with Auer rods and extramedullary disease (EMD).

CR: MLFS criteria; absolute neutrophil count (ANC)>1000/ul and platelet >100,000/ul; independence from red cell transfusions.

CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.

CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Objective Response Rate (ORR) - Percentage of Participants With Objective Response [Part 1]	NA percentage of participants Data could not be analyzed as there were 2 treatment failures and 1 non-evaluable participant in this arm. Non-evaluable was due to no post-dose assessment for response.	NA percentage of participants Data could not be analyzed as there were 2 treatment failures and 2 non-evaluable participants in this arm. Non-evaluable was due to no post-dose assessment for response.	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: All enrolled participants who received at least 1 dose of study treatment and had a baseline disease assessment.

Duration of ORR is the time from first documentation of MLFS, CR, CRc, CRm, PR, CRi or PRi to date of first documentation of disease progression or death due to any cause.

MLFS: BM blasts <5%; absence of blasts with Auer rods and EMD. CR: MLFS criteria; ANC>1000/ul and platelet >100,000/ul; independence from red cell transfusions.

CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.

CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.

Disease progression/relapse: BM blast ≥5%; or reappearance of blast in the blood; or development of EMD.

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Duration of Objective Response Rate (ORR) [Part 1]	NA months Data could not be analyzed as there were 2 treatment failures and 1 non-evaluable participant in this arm. Non-evaluable was due to no post-dose assessment for response.	NA months Data could not be analyzed as there were 2 treatment failures and 2 non-evaluable participants in this arm. Non-evaluable was due to no post-dose assessment for response.	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Population: All enrolled participants who received at least 1 dose of study treatment and had a baseline disease assessment.

Progression/relapse free survival is the time from the start of study treatment to first documentation of disease progression or to death due to any cause, whichever occurrs first. Disease progression/relapse: Bone marrow blast ≥ 5%; or reappearance of blast in the blood; or development of extramedullary disease (EMD).

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Progression Free Survival [Part 1]	NA months Data could not be analyzed as there were 2 treatment failures and 1 non-evaluable participant in this arm. Non-evaluable was due to no post-dose assessment for response.	NA months Data could not be analyzed as there were 2 treatment failures and 2 non-evaluable participants in this arm. Non-evaluable was due to no post-dose assessment for response.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, end of treatment

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

Samples were tested for ADA using a validated assay. Number of participants with positive ADA samples was determined.

Outcome measures

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 Participants PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 Participants PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.	Part 2: PF-06747143 Combined With Cytarabine and Daunorubicin This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard intensive 7+3 chemotherapy with cytarabine (100-200 mg/m2 continuous infusion for 7 days) and daunorubicin (60-90 mg/m2 daily for 3 days) in Part 2.	Part 2: PF-06747143 Combined With Azacitidine or Decitabine This arm was not initiated due to early termination of the study. PF-06747143 was planned to be administered as an intravenous infusion once weekly at 10 mg/kg in 28-day cycles in combination with standard dose of azacitidine (75 mg/m2 administered subcutaneously or intravenously daily for 7 days) or decitabine (20 mg/m2 by continuous intravenous infusion over 1 hour daily for 5 days in a 4-week schedule) in Part 2.
Incidence of Anti-Drug Antibodies (ADA) Against PF-06747143 [Part 1] Cycle 1 Day 1	0 Participants	1 Participants	—	—	—
Incidence of Anti-Drug Antibodies (ADA) Against PF-06747143 [Part 1] End of treatment	0 Participants	0 Participants	—	—	—
Incidence of Anti-Drug Antibodies (ADA) Against PF-06747143 [Part 1] Cycle 1 Day 15	0 Participants	0 Participants	—	—	—
Incidence of Anti-Drug Antibodies (ADA) Against PF-06747143 [Part 1] Cycle 2 Day 1	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, end of treatment

Population: No data was collected as Nab analysis was not performed.

Samples tested positive for ADA were to be further analyzed for Nab using a validated assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 and 15 pre-dose of Cycle 1, Day 1 pre-dose of Cycles 2-6, Day 1 pre-dose of every 3 cycles thereafter, and at end of treatment

Population: Part 2 was not conducted.

Samples were to be analyzed for ADA using a validated assay. ADA positive samples were to be further analyzed for Nab using a validated assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 pharmacokinetics (PK) assessments were not completed and Part 2 was not conducted.

Cmax of PF-06747143 was the peak serum concentration to be observed directly from data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

Tmax of PF-06747143 was to be observed directly from data as time of first occurrence of peak serum concentration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

AUClast is area under the serum concentration versus time profile from time zero to the time of the last quantifiable concentration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

AUCinf is area under the serum concentration versus time profile from time zero extrapolated to infinite time. If data permitted, AUCinf was to be estimated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

t1/2 is the time measured for the serum concentration to decrease by one half. If data permitted, t1/2 was to be estimated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

Assuming steady state was achieved, Cmax,ss was to be determined following multiple dosing to characterize the PK.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

Cmin is the minimum observed serum concentration. Assuming steady state was achieved, Cmin,ss was to be determined following multiple dosing to characterize the PK.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

AUCtau is area under the serum concentration versus time profile from time zero to the time tau (ie, dosing interval). Assuming steady state was achieved, AUCtau,ss was to be determined following multiple dosing to characterize the PK.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

Accumulation ratio (Rac) was to be obtained from AUCtau at steady state (AUCtau,ss) divided by AUCtau after single dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

If data permitted, CL was to be determined following multiple dosing to characterize the PK.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

Vss is the apparent volume of distribution at steady-state. If data permitted, Vss was to be determined following multiple dosing to characterize the PK.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.

t1/2 is the time measured for the serum concentration to decrease by one half.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment

Population: Part 2 was not conducted.

Peak and trough PF-06747143 concentrations were to be observed directly from data.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: PF-06747143 0.3 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Part 1: PF-06747143 1 mg/kg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 participants at risk PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 participants at risk PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.
General disorders Pyrexia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Cellulitis	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Pneumonia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Sepsis	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Measure	Part 1: PF-06747143 0.3 mg/kg n=3 participants at risk PF-06747143 was administered as an intravenous infusion once weekly at 0.3 mg/kg in 28-day cycles.	Part 1: PF-06747143 1 mg/kg n=4 participants at risk PF-06747143 was administered as an intravenous infusion once weekly at 1 mg/kg in 28-day cycles.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Leukocytosis	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Cardiac disorders Tachycardia	66.7% 2/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Abdominal pain lower	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Constipation	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	100.0% 3/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Asthenia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Chills	66.7% 2/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Fatigue	66.7% 2/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Malaise	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Mucosal inflammation	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Oedema peripheral	66.7% 2/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
General disorders Pyrexia	100.0% 3/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	75.0% 3/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Hepatobiliary disorders Hyperbilirubinaemia	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Immune system disorders Drug hypersensitivity	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Pneumonia	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Sinusitis	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Allergic transfusion reaction	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Injury, poisoning and procedural complications Transfusion reaction	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Blood bilirubin increased	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Blood phosphorus increased	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Electrocardiogram QT prolonged	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Hepatic enzyme increased	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Lymphocyte count decreased	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Investigations Oxygen saturation decreased	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypocalcaemia	66.7% 2/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	75.0% 3/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	50.0% 2/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Headache	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Restless legs syndrome	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Hallucination	66.7% 2/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Psychiatric disorders Mental status changes	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Rales	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Eczema	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Petechiae	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Skin and subcutaneous tissue disorders Purpura	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Haematoma	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypertension	33.3% 1/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	0.00% 0/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypotension	0.00% 0/3 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.	25.0% 1/4 • 1 year The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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