MELANOMA, NSCLC, OTHER SOLID TUMORS, OVCA, Part 1, Part 1 and 2, SARCOMA, SCCHN, UROTHELIAL CARCINOMA
Conditions
Keywords
efficacy, safety, pharmacokinetics, pharmacodynamics, open label, dose response, multiple ascending dose, immunogenicity, recommended phase 2 dose, subcutaneous
Brief summary
Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose.
Detailed description
Protocol B8011001 is a Phase 1, two part, open-label, multi center, multiple-dose, safety, efficacy, PK, and PD study of PF-06801591 administered intravenously (IV) or subcutaneous (SC) in previously treated adult patients with locally advanced or metastatic melanoma, squamous cell carcinoma head and neck (SCCHN), ovarian carcinoma, sarcoma, non-small cell lung carcinoma (NSCLC), urothelial carcinoma or other solid tumors. The first part of the study, Part 1 dose escalation, was designed to assess the safety and tolerability of increasing dose levels of IV or SC administered PF-06801591 to establish the maximum tolerated dose (MTD) using a modified Toxicity Probability Interval (mTPI) design. Part 2 expansion is designed to further evaluate the safety and efficacy of 300 mg of PF-06801591 administered SC once every 4 weeks in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose (RP2D). Part 1 enrollment has completed, enrollment will only be allowed for Part 2.
Interventions
DRUGPF-06801591
IV every 21 days (Part 1)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Part 2 Only): * Histological or cytological diagnosis of locally advanced or metastatic NSCLC or urothelial carcinoma who have progressed on or were intolerant to standard of care systemic therapy, or for whom standard of care systemic therapy was refused (refusal must be documented) or unavailable. * No prior treatment with anti-PD-1 or anti-PD-L1 therapy. * NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have progressed on or after no more than 1 prior line of platinum-containing systemic therapy or were intolerant or refused standard of care systemic therapy. * NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must have progressed on or after both types of therapies. * Urothelial carcinoma patients must have received up to 2 lines of prior systemic therapy and progressed on or after, experienced disease recurrence within 12 months of neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused platinum-containing systemic therapy. If urothelial cancer patients are treatment naïve and eligible for platinum-containing systemic therapy but are refusing platinum chemotherapy, they must also be documented to have previous PD-L1 high status. * Provide archived tumor tissue sample taken within the past 2 years or provide a fresh tumor biopsy sample. * At least one measurable lesion as defined by RECIST version 1.1. * Adequate renal, liver, thyroid and bone marrow function. * Performance status 0 or 1. * Patient is capable of receiving study treatment for at least 8 weeks.
Exclusion criteria
(Part 2 Only) * Active brain or leptomeningeal metastases. * Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy or prior allogeneic bone marrow or hematopoietic stem cell transplant. * Patients with a condition requiring systemic treatment with either corticosteroids (\>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Patients with a history of interstitial lung disease, non-infectious pneumonitis, or active pulmonary tuberculosis. Those with active lung infections requiring treatment are also excluded. * History of Grade ≥3 immune mediated AE (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy. * Active hepatitis B or C, HIV/AIDS. * Other potentially metastatic malignancy within past 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591) | DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE. |
| Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE. |
| Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE. |
| Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed. |
| Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | Baseline up to 28 days after last dose of study treatment (maximum of 1634 days) | Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \[GGT\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \[INR\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE. |
| Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | ORR was defined as percentage of participants with objective response (OR) of complete response (CR) and partial response (PR) based on irRECIST. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 851 days) | Number of participants with ADA positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was ADA positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were ADA positive at baseline but did not become boosted post-treatment were considered as ADA negative. |
| Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 851 days) | Number of participants with NAb positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were NAb positive at baseline but did not become boosted post-treatment were considered as NAb negative. |
| Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing) | PD-1 RO by sasanlimab was measured by the reduction of free receptor on the surface of CD8+ effector cells (CD3+, CD4-, CD8+, CD45RA+, CCR7-, CD279+) and CD8+ effector memory cells (CD3+, CD4-, CD8+, CD45RA-, CCR7-, CD279+) presented in pre- and postdose whole blood samples by flow cytometry. Percentage of baseline (ie, normalized change from baseline) PD-1 RO were calculated as \[(percentage of cells at Cycle X Day X)/(percentage of cells at baseline)\]\*100, and are reported for this outcome measure. Baseline was defined as the most recent non-missing value prior to dosing. |
| Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 | Baseline up to end of treatment in Part 1 (maximum of 1606 days) | Number of participants achieving confirmed OR based on RECIST version 1.1 in Part 1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed. |
| Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | Probability of survival was calculated from the product-limit method. |
| Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 | Baseline up to end of treatment in Part 1 (maximum of 1606 days) | Number of participants achieving confirmed OR based on irRECIST in Part 1. OR = irCR + irPR. Overall immune related complete response (irCR) was defined as complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR) was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases \>=30%. |
| Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Cmax was the maximum concentration after dose administration observed directly from the data. |
| Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 1606 days) | DOSD was analyzed by the Kaplan-Meier approach for each tumor type. Stable disease (SD) was defined as not qualifying for complete response (CR), partial response (PR), or progression. All target lesions must have been assessed. Stable could follow PR only in the rare case that the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer held. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed. |
| Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 1606 days) | DOR was defined as the time from start date (which was the date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group. |
| Time to Response (TTR) Based on RECIST Version 1.1 - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | TTR was the time to confirmed or unconfirmed complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1 by tumor type. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed. |
| Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | TTP was the time to objective progression. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. TTP was analyzed by the Kaplan-Meier approach for each tumor type. |
| Median Time to Death - Part 2 | Baseline up to end of treatment in Part 2 (maximum of 851 days) | Median time to death was analyzed by the Kaplan-Meier approach for each tumor type. |
| Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2 | Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data. |
| Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | Baseline up to end of treatment (maximum of 1606 days) | PFS was defined as the time from initiation of study intervention to first documentation of tumor progression or to death due to any cause, whichever occurred first. PFS was analyzed by the Kaplan-Meier approach for each tumor type. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group. |
| AUClast of PF-06801591 in Part 1. | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1 | Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1 |
| Clearance (CL) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm. |
| Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1 | Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1 | Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL\*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity. |
| Accumulation Ratio (Rac) of PF-06801591 - Part 1 | Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1 | Rac was calculated by (Cycle 4 AUCtau) / (Cycle 1 AUCtau). AUCtau was Area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for Q3W IV dosing and tau = 672 hours for every 4 weeks (Q4W) SC dosing. |
| Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1 | Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1 | t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. |
Countries
Bulgaria, Malaysia, Poland, Russia, South Korea, Ukraine, United States
Participant flow
Pre-assignment details
A total of 147 participants were enrolled in this study, and 146 participants received study treatment. For Part 1, 40 participants were enrolled and treated. For Part 2, 107 participants were enrolled including 68 participants with non small cell lung cancer (NSCLC) and 39 participants with urothelial carcinoma (UC), and 106 participants received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days) | 2 |
| Part 1: PF-06801591 1 mg/kg (IV) Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days) | 8 |
| Part 1: PF-06801591 3 mg/kg (IV) Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days) | 8 |
| Part 1: PF-06801591 10 mg/kg (IV) Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days) | 7 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days) | 15 |
| Part 2: PF-06801591 300 mg (SC) for NSCLC Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days) | 68 |
| Part 2: PF-06801591 300 mg (SC) for UC Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days) | 38 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 6 | 5 | 6 | 9 | 32 | 21 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 1 | 4 | 5 |
| Overall Study | Participant refused further follow-up | 0 | 2 | 1 | 0 | 3 | 20 | 7 |
Baseline characteristics
| Characteristic | Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Part 1: PF-06801591 1 mg/kg (IV) | Part 1: PF-06801591 3 mg/kg (IV) | Part 1: PF-06801591 10 mg/kg (IV) | Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Part 2: PF-06801591 300 mg (SC) for NSCLC | Part 2: PF-06801591 300 mg (SC) for UC | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-44 Years | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Customized 45-64 Years | 1 Participants | 3 Participants | 5 Participants | 3 Participants | 10 Participants | 28 Participants | 16 Participants | 66 Participants |
| Age, Customized >=65 Years | 1 Participants | 5 Participants | 2 Participants | 3 Participants | 5 Participants | 39 Participants | 21 Participants | 76 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 18 Participants | 8 Participants | 29 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 7 Participants | 7 Participants | 4 Participants | 12 Participants | 50 Participants | 30 Participants | 112 Participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 5 Participants | 4 Participants | 11 Participants | 15 Participants | 13 Participants | 56 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 53 Participants | 25 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 6 / 8 | 5 / 8 | 6 / 7 | 10 / 15 | 18 / 25 | 28 / 40 | 33 / 68 | 21 / 38 | 54 / 106 |
| other Total, other adverse events | 2 / 2 | 7 / 8 | 8 / 8 | 7 / 7 | 15 / 15 | 24 / 25 | 39 / 40 | 59 / 68 | 33 / 38 | 92 / 106 |
| serious Total, serious adverse events | 1 / 2 | 3 / 8 | 3 / 8 | 3 / 7 | 3 / 15 | 10 / 25 | 13 / 40 | 18 / 68 | 13 / 38 | 31 / 106 |
Outcome results
Primary
Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
Time frame: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
Population: Analysis population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 3 or 4 AEs | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 5 AEs | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 5 AEs | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 3 or 4 AEs | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 3 or 4 AEs | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 5 AEs | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 3 or 4 AEs | 2 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 5 AEs | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 15 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 5 AEs | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 3 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 3 or 4 AEs | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 18 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 62 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 3 or 4 AEs | 18 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 5 AEs | 8 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 3 or 4 AEs | 13 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 36 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 13 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum Grade 5 AEs | 5 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2
Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \[GGT\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \[INR\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
Time frame: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
Population: Analysis population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 0 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 0 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 1 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 0 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 0 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 2 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 1 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 3 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 0 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 0 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 0 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 4 | NA Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 0 | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 0 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 0 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 4 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 2 | 4 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 1 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 1 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 0 | 4 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 0 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 0 | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 1 | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 3 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 3 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 0 | 4 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 2 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 0 | 3 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 0 | 4 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 4 | NA Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 2 | 2 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 0 | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 0 | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 4 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 4 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 0 | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 0 | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 0 | 4 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 1 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 2 | 2 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 0 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 2 | 6 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 0 | 6 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 0 | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 1 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 0 | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 2 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 1 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 1 | 4 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 0 | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 0 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 2 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 1 | 4 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 1 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 0 | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 0 | 8 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 0 | 4 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 4 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 1 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 1 | 4 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 0 | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 0 | 4 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 0 | 4 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 1 | 4 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 1 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 3 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 0 | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 0 | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 4 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 0 | 5 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 2 | 4 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 0 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 0 | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 2 | 2 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 1 | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 1 | 5 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 0 | 5 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 0 | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 0 | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 0 | 4 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 1 | NA Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 0 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 0 | 15 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 4 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 0 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 1 | 5 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 2 | 8 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 3 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 0 | 15 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 0 | 9 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 1 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 3 | 3 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 0 | 14 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 1 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 4 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 0 | 12 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 0 | 10 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 1 | 4 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 0 | 14 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 0 | 6 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 1 | 7 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 2 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 0 | 11 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 1 | 4 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 1 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 2 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 3 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 0 | 14 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 3 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 0 | 15 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 1 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 3 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 0 | 9 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 1 | 6 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 0 | 11 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 1 | 4 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 4 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 0 | 12 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 1 | 3 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 0 | 10 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 2 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 3 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 4 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 1 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 2 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 0 | 15 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 0 | 10 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 1 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 2 | 4 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 3 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 0 | 8 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 1 | 5 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 2 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 0 | 8 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 1 | 5 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 2 | NA Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 3 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 0 | 15 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 1 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 3 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 4 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 0 | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 1 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 1 | 25 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 0 | 48 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 0 | 60 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 2 | 10 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 3 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 1 | 31 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 0 | 24 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 0 | 40 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 1 | 15 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 0 | 51 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 1 | 18 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 2 | 10 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 1 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 0 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 0 | 49 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 1 | 6 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 1 | 12 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 0 | 58 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CPK INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CPK INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CPK INCREASED | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 2 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CPK INCREASED | Grade 1 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CPK INCREASED | Grade 0 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 2 | 13 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 1 | 6 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 0 | 58 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 0 | 60 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 2 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 1 | 17 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 0 | 50 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 0 | 44 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 1 | 38 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 2 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 1 | 22 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 0 | 61 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 0 | 36 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 2 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 0 | 16 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 1 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 1 | 19 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 0 | 45 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 1 | 11 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 1 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 0 | 42 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 0 | 62 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 1 | 14 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 1 | 16 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 2 | 8 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 1 | 12 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 0 | 56 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 0 | 45 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 3 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 2 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 1 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 0 | 45 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 0 | 61 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 2 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 1 | 19 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 2 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 2 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 1 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 4 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 0 | 63 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 3 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 2 | 15 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 0 | 39 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 0 | 56 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 1 | 21 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 0 | 27 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 1 | 8 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 1 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 2 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 1 | 15 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 0 | 46 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 2 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 2 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 2 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 0 | 44 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 1 | 8 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 0 | 51 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 1 | 19 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 3 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 2 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 2 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 1 | 6 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 1 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 0 | 55 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 2 | 11 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 1 | 8 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 0 | 31 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 1 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 1 | 6 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 0 | 23 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 0 | 35 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 1 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 0 | 31 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 3 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 2 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 3 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 1 | 21 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | INR INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERGLYCEMIA | Grade 0 | 12 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 4 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 1 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 2 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 0 | 23 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 1 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 1 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 2 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERCALCEMIA | Grade 0 | 31 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 0 | 29 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | WHITE BLOOD CELL DECREASED | Grade 0 | 34 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 1 | 11 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 1 | 11 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 3 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 2 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 1 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 1 | 10 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 1 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 1 | 8 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | GGT INCREASED | Grade 0 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 0 | 27 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOALBUMINEMIA | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT DECREASED | Grade 0 | 20 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 2 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 2 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 0 | 30 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 1 | 30 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 1 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | CREATININE INCREASED | Grade 0 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PLATELET COUNT DECREASED | Grade 0 | 33 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 1 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 0 | 19 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOPHOSPHATEMIA | Grade 1 | 7 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 2 | 9 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 1 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 2 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOMAGNESEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 1 | 16 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HEMOGLOBIN INCREASED | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOCALCEMIA | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 1 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 1 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | BLOOD BILIRUBIN INCREASED | Grade 0 | 34 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERNATREMIA | Grade 0 | 35 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 3 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 0 | 32 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 4 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 2 | 5 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 0 | 25 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 1 | 6 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | NEUTROPHIL COUNT DECREASED | Grade 0 | 35 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 1 | 13 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 1 | 17 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 0 | 35 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ASPARTATE AMINOTRANSFERASE INCREASED | Grade 0 | 23 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 0 | 15 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 0 | 23 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 1 | 10 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERMAGNESEMIA | Grade 1 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 3 | 2 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 3 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 2 | 4 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPERKALEMIA | Grade 0 | 27 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOGLYCEMIA | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LIPASE INCREASED | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 1 | 11 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 4 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALKALINE PHOSPHATASE INCREASED | Grade 0 | 21 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ANEMIA | Grade 0 | 6 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 2 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 0 | 33 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | PROTEINURIA | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 1 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 3 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 4 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | LYMPHOCYTE COUNT INCREASED | Grade 0 | 37 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Grade 1 | 15 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPOKALEMIA | Grade 1 | NA Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | SERUM AMYLASE INCREASED | Grade 3 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | ALANINE AMINOTRANSFERASE INCREASED | Grade 2 | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2 | HYPONATREMIA | Grade 3 | 2 Participants |
Primary
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
Time frame: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
Population: Analysis population included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 2 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 5 AEs | 0 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 3 or 4 AEs | 1 Participants |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 5 AEs | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 6 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 3 or 4 AEs | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 5 AEs | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 0 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 3 or 4 AEs | 1 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 7 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 0 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 6 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 3 or 4 AEs | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 5 AEs | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 5 AEs | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 13 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 3 or 4 AEs | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 42 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 3 or 4 AEs | 9 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 5 AEs | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with SAEs | 3 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with AEs | 17 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 5 AEs | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2 | Participants with maximum of Grade 3 or 4 AEs | 5 Participants |
Primary
Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2
ORR was defined as percentage of participants with objective response (OR) of complete response (CR) and partial response (PR) based on irRECIST. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.
Time frame: Baseline up to end of treatment in Part 2 (maximum of 851 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2 | 19.4 Percentage of Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2 | 21.1 Percentage of Participants |
Primary
Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2
ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.
Time frame: Baseline up to end of treatment in Part 2 (maximum of 851 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2 | 16.4 Percentage |
| Part 1: PF-06801591 1 mg/kg (IV) | Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2 | 18.4 Percentage |
Primary
Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.
Time frame: Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)
Population: DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | 0 Percentage of Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | 0 Percentage of Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | 0 Percentage of Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | 0 Percentage of Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1 | 0 Percentage of Participants |
Secondary
Accumulation Ratio (Rac) of PF-06801591 - Part 1
Rac was calculated by (Cycle 4 AUCtau) / (Cycle 1 AUCtau). AUCtau was Area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for Q3W IV dosing and tau = 672 hours for every 4 weeks (Q4W) SC dosing.
Time frame: Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1
Population: Analysis population included all enrolled participants treated who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Accumulation Ratio (Rac) of PF-06801591 - Part 1 | NA Ratio | — |
| Part 1: PF-06801591 1 mg/kg (IV) | Accumulation Ratio (Rac) of PF-06801591 - Part 1 | NA Ratio | — |
| Part 1: PF-06801591 3 mg/kg (IV) | Accumulation Ratio (Rac) of PF-06801591 - Part 1 | NA Ratio | — |
| Part 1: PF-06801591 10 mg/kg (IV) | Accumulation Ratio (Rac) of PF-06801591 - Part 1 | 2.360 Ratio | Geometric Coefficient of Variation 12 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Accumulation Ratio (Rac) of PF-06801591 - Part 1 | 2.073 Ratio | Geometric Coefficient of Variation 31 |
Secondary
AUClast of PF-06801591 in Part 1.
Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1
Time frame: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1
Population: Analysis population included all enrolled participants treated who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | AUClast of PF-06801591 in Part 1. | NA ug*hr/mL | — |
| Part 1: PF-06801591 1 mg/kg (IV) | AUClast of PF-06801591 in Part 1. | 4700 ug*hr/mL | Geometric Coefficient of Variation 41 |
| Part 1: PF-06801591 3 mg/kg (IV) | AUClast of PF-06801591 in Part 1. | 14770 ug*hr/mL | Geometric Coefficient of Variation 27 |
| Part 1: PF-06801591 10 mg/kg (IV) | AUClast of PF-06801591 in Part 1. | 46780 ug*hr/mL | Geometric Coefficient of Variation 49 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | AUClast of PF-06801591 in Part 1. | 9923 ug*hr/mL | Geometric Coefficient of Variation 65 |
Secondary
Clearance (CL) of PF-06801591 - Part 1
CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm.
Time frame: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1
Population: Analysis population included all enrolled participants treated who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Clearance (CL) of PF-06801591 - Part 1 | Cycle 4 Day 1 | NA L/hr | — |
| Part 1: PF-06801591 1 mg/kg (IV) | Clearance (CL) of PF-06801591 - Part 1 | Cycle 1 Day 1 | NA L/hr | — |
| Part 1: PF-06801591 1 mg/kg (IV) | Clearance (CL) of PF-06801591 - Part 1 | Cycle 4 Day 1 | NA L/hr | — |
| Part 1: PF-06801591 3 mg/kg (IV) | Clearance (CL) of PF-06801591 - Part 1 | Cycle 4 Day 1 | 0.006045 L/hr | Geometric Coefficient of Variation 57 |
| Part 1: PF-06801591 10 mg/kg (IV) | Clearance (CL) of PF-06801591 - Part 1 | Cycle 4 Day 1 | 0.004984 L/hr | Geometric Coefficient of Variation 14 |
Secondary
Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
DOR was defined as the time from start date (which was the date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.
Time frame: Baseline up to end of treatment (maximum of 1606 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. DOR was only applicable to those participants with an objective response.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 9.7 Months |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 13.0 Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | NA Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | NA Months |
| Part 1: PF-06801591 3 mg/kg (IV) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 21.8 Months |
| Part 1: PF-06801591 3 mg/kg (IV) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 22.1 Months |
| Part 1: PF-06801591 10 mg/kg (IV) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 13.9 Months |
| Part 1: PF-06801591 10 mg/kg (IV) | Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | NA Months |
Secondary
Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
DOSD was analyzed by the Kaplan-Meier approach for each tumor type. Stable disease (SD) was defined as not qualifying for complete response (CR), partial response (PR), or progression. All target lesions must have been assessed. Stable could follow PR only in the rare case that the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer held. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.
Time frame: Baseline up to end of treatment (maximum of 1606 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | NA Months |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | NA Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | NA Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | NA Months |
| Part 1: PF-06801591 3 mg/kg (IV) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 24.3 Months |
| Part 1: PF-06801591 3 mg/kg (IV) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 29.0 Months |
| Part 1: PF-06801591 10 mg/kg (IV) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 5.7 Months |
| Part 1: PF-06801591 10 mg/kg (IV) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 5.7 Months |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 6.0 Months |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 13.7 Months |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 6.5 Months |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 7.5 Months |
| Part 2: PF-06801591 300 mg (SC) for UC | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 8.5 Months |
| Part 2: PF-06801591 300 mg (SC) for UC | Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 14.5 Months |
Secondary
Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1
Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1
Population: Analysis population included all enrolled participants treated who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 4 Day 1 | NA ug/mL | — |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 1 Day 1 | NA ug/mL | — |
| Part 1: PF-06801591 1 mg/kg (IV) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 4 Day 1 | 30.10 ug/mL | Geometric Coefficient of Variation 16 |
| Part 1: PF-06801591 1 mg/kg (IV) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 1 Day 1 | 21.52 ug/mL | Geometric Coefficient of Variation 23 |
| Part 1: PF-06801591 3 mg/kg (IV) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 1 Day 1 | 69.63 ug/mL | Geometric Coefficient of Variation 28 |
| Part 1: PF-06801591 3 mg/kg (IV) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 4 Day 1 | 86.34 ug/mL | Geometric Coefficient of Variation 52 |
| Part 1: PF-06801591 10 mg/kg (IV) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 1 Day 1 | 217.2 ug/mL | Geometric Coefficient of Variation 36 |
| Part 1: PF-06801591 10 mg/kg (IV) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 4 Day 1 | 402.6 ug/mL | Geometric Coefficient of Variation 42 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 4 Day 1 | 56.48 ug/mL | Geometric Coefficient of Variation 29 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1 | Cycle 1 Day 1 | 21.24 ug/mL | Geometric Coefficient of Variation 50 |
Secondary
Median Time to Death - Part 2
Median time to death was analyzed by the Kaplan-Meier approach for each tumor type.
Time frame: Baseline up to end of treatment in Part 2 (maximum of 851 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Median Time to Death - Part 2 | 14.7 Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Median Time to Death - Part 2 | 10.9 Months |
Secondary
Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1
Number of participants achieving confirmed OR based on irRECIST in Part 1. OR = irCR + irPR. Overall immune related complete response (irCR) was defined as complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR) was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases \>=30%.
Time frame: Baseline up to end of treatment in Part 1 (maximum of 1606 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 | 2 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1 | 1 Participants |
Secondary
Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1
Number of participants achieving confirmed OR based on RECIST version 1.1 in Part 1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.
Time frame: Baseline up to end of treatment in Part 1 (maximum of 1606 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 | 2 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 | 2 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1 | 1 Participants |
Secondary
Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2
Number of participants with ADA positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was ADA positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were ADA positive at baseline but did not become boosted post-treatment were considered as ADA negative.
Time frame: Baseline up to end of treatment (maximum of 851 days)
Population: Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | 1 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | 5 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | 3 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | 1 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | 1 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2 | 0 Participants |
Secondary
Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2
Number of participants with NAb positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were NAb positive at baseline but did not become boosted post-treatment were considered as NAb negative.
Time frame: Baseline up to end of treatment (maximum of 851 days)
Population: Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result. NAb-negative participants included participants who were ADA negative or ADA-positive participants who tested negative in the NAb assay.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | 0 Participants |
| Part 1: PF-06801591 1 mg/kg (IV) | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | 3 Participants |
| Part 1: PF-06801591 3 mg/kg (IV) | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | 1 Participants |
| Part 1: PF-06801591 10 mg/kg (IV) | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | 0 Participants |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | 0 Participants |
| Part 2: PF-06801591 300 mg (SC) for UC | Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2 | 0 Participants |
Secondary
Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1
PD-1 RO by sasanlimab was measured by the reduction of free receptor on the surface of CD8+ effector cells (CD3+, CD4-, CD8+, CD45RA+, CCR7-, CD279+) and CD8+ effector memory cells (CD3+, CD4-, CD8+, CD45RA-, CCR7-, CD279+) presented in pre- and postdose whole blood samples by flow cytometry. Percentage of baseline (ie, normalized change from baseline) PD-1 RO were calculated as \[(percentage of cells at Cycle X Day X)/(percentage of cells at baseline)\]\*100, and are reported for this outcome measure. Baseline was defined as the most recent non-missing value prior to dosing.
Time frame: Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing)
Population: Analysis population included all enrolled participants with at least 1 of the pharmacodynamic/biomarker parameters evaluated at pre- and/or post dose.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 5 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 1 | 0.80 Percentage of Baseline |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 3 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 8 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 2 Day 1 | 1.48 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 5 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | EOT | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 3 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 8 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 2 Day 1 | 0.04 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 1 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 1 | 0.05 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 1 | 0.56 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 8 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 2 Day 1 | 0.82 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 3 Day 1 | 0.47 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 5 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 3 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | EOT | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 8 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | EOT | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 5 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 1 | 0.02 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 3 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 10 mg/kg (IV) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 2 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 5 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 2 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 3 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 21 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 1 | 0.32 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 1 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 15 | 0.57 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | EOT | 0.17 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 15 | 0.00 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 4 Day 21 | 1.31 Percentage of Baseline |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1 | Cycle 1 Day 8 | 0.00 Percentage of Baseline |
Secondary
Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2
Probability of survival was calculated from the product-limit method.
Time frame: Baseline up to end of treatment in Part 2 (maximum of 851 days)
Population: Analysis population included all the randomized participants who received PF-06801591 and had at least 1 post-dose concentration measurement above the lower limit of quantification (LLQ).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 | 6 Months | 0.773 Probability |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 | 2 Years | 0.403 Probability |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 | 1 Year | 0.547 Probability |
| Part 1: PF-06801591 1 mg/kg (IV) | Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 | 2 Years | 0.286 Probability |
| Part 1: PF-06801591 1 mg/kg (IV) | Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 | 6 Months | 0.711 Probability |
| Part 1: PF-06801591 1 mg/kg (IV) | Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2 | 1 Year | 0.471 Probability |
Secondary
Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
PFS was defined as the time from initiation of study intervention to first documentation of tumor progression or to death due to any cause, whichever occurred first. PFS was analyzed by the Kaplan-Meier approach for each tumor type. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.
Time frame: Baseline up to end of treatment (maximum of 1606 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 4.7 Months |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 4.9 Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 3.0 Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 4.5 Months |
| Part 1: PF-06801591 3 mg/kg (IV) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 5.5 Months |
| Part 1: PF-06801591 3 mg/kg (IV) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 3.7 Months |
| Part 1: PF-06801591 10 mg/kg (IV) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | irRECIST | 3.8 Months |
| Part 1: PF-06801591 10 mg/kg (IV) | Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2 | RECIST v1.1 | 2.9 Months |
Secondary
Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1
t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Time frame: Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1
Population: The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV or SC administration and had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of t1/2.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1: PF-06801591 1 mg/kg (IV) | Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1 | Cycle 1 Day 1 | NA Days |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1 | Cycle 4 Day 1 | NA Days |
Secondary
Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2
TTP was the time to objective progression. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. TTP was analyzed by the Kaplan-Meier approach for each tumor type.
Time frame: Baseline up to end of treatment in Part 2 (maximum of 851 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2 | RECIST v1.1 | 3.7 Months |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2 | irRECIST | 6.5 Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2 | irRECIST | 8.5 Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2 | RECIST v1.1 | 3.7 Months |
Secondary
Time to Response (TTR) Based on RECIST Version 1.1 - Part 2
TTR was the time to confirmed or unconfirmed complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1 by tumor type. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.
Time frame: Baseline up to end of treatment in Part 2 (maximum of 851 days)
Population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Time to Response (TTR) Based on RECIST Version 1.1 - Part 2 | 2.71 Months |
| Part 1: PF-06801591 1 mg/kg (IV) | Time to Response (TTR) Based on RECIST Version 1.1 - Part 2 | 2.33 Months |
Secondary
Trough PF-06801591 Concentrations (Ctrough) - Part 2
Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data.
Time frame: Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2
Population: Analysis population included all participants who received PF-06801591, had no protocol deviations affecting the pharmacokinetics (PK) assessment, and had at least 1 post-dose concentration measurement above lower limit of quantification.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 2 Day 1 | 14.97 ug/mL | Geometric Coefficient of Variation 48 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 3 Day 1 | 22.54 ug/mL | Geometric Coefficient of Variation 37 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 4 Day 1 | 23.55 ug/mL | Geometric Coefficient of Variation 53 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 5 Day 1 | 23.58 ug/mL | Geometric Coefficient of Variation 41 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 6 Day 1 | 29.67 ug/mL | Geometric Coefficient of Variation 36 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 9 Day 1 | 29.01 ug/mL | Geometric Coefficient of Variation 36 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 12 Day 1 | 34.29 ug/mL | Geometric Coefficient of Variation 16 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 15 Day 1 | 40.90 ug/mL | Geometric Coefficient of Variation 22 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 18 Day 1 | 35.09 ug/mL | Geometric Coefficient of Variation 25 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 21 Day 1 | 27.16 ug/mL | Geometric Coefficient of Variation 25 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 24 Day 1 | 30.81 ug/mL | Geometric Coefficient of Variation 16 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Follow-up Day 28 | 43.62 ug/mL | Geometric Coefficient of Variation 33 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 24 Day 1 | 38.02 ug/mL | Geometric Coefficient of Variation 38 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 2 Day 1 | 14.34 ug/mL | Geometric Coefficient of Variation 73 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 12 Day 1 | 12.74 ug/mL | Geometric Coefficient of Variation 770 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 3 Day 1 | 20.15 ug/mL | Geometric Coefficient of Variation 84 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 21 Day 1 | 22.11 ug/mL | Geometric Coefficient of Variation 55 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 4 Day 1 | 23.77 ug/mL | Geometric Coefficient of Variation 60 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 15 Day 1 | 22.10 ug/mL | Geometric Coefficient of Variation 56 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 5 Day 1 | 19.32 ug/mL | Geometric Coefficient of Variation 186 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Follow-up Day 28 | 35.17 ug/mL | Geometric Coefficient of Variation 32 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 6 Day 1 | 17.13 ug/mL | Geometric Coefficient of Variation 249 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 18 Day 1 | 20.17 ug/mL | Geometric Coefficient of Variation 75 |
| Part 1: PF-06801591 1 mg/kg (IV) | Trough PF-06801591 Concentrations (Ctrough) - Part 2 | Cycle 9 Day 1 | 29.88 ug/mL | Geometric Coefficient of Variation 30 |
Secondary
Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1
Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL\*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity.
Time frame: Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1
Population: The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV administration and had sufficient information to estimate at least 1 of the pharmacokinetic (PK) parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants who had reportable parameter values of Vss.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1: PF-06801591 1 mg/kg (IV) | Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1 | Cycle 1 Day 1 | NA L |