A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02573259
• Collaborator: (none)
• Enrollment: 147
• Locations: 67
• Arms: 5
• Actual Duration (Months): 57.3
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Part 1; MELANOMA; SCCHN; OVCA; SARCOMA; OTHER SOLID TUMORS; Part 1 and 2; NSCLC; UROTHELIAL CARCINOMA	Drug: PF-06801591; Drug: PF-06801591	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 147 participants
• Allocation: Non-Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-06801591 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC MELANOMA, SQUAMOUS CELL HEAD AND NECK CANCER, OVARIAN CANCER, SARCOMA, NON-SMALL CELL LUNG CANCER, UROTHELIAL CARCINOMA OR OTHER SOLID TUMORS.
• Actual Study Start Date: Feb 10, 2016
• Actual Primary Completion Date: Nov 19, 2020
• Actual Study Completion Date: Nov 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 PF-06801591 0.5 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 2 PF-06801591 1.0 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 3 PF-06801591 3.0 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 4 PF-06801591 10 mg/kg IV every 21 days (Part 1)	Drug: PF-06801591; IV every 21 days (Part 1)
Experimental: Arm 5 PF-06801591 300 mg SC every 28 days (Part 1 and 2)	Drug: PF-06801591; 300 mg SC every 28 days (Part 1 and 2)

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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 Outcome Measures

1. 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.

2. 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

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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%.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Unit	Los Angeles	California	United States	90024
2	Ronald Reagan Medical Center, Department of Radiological Sciences	Los Angeles	California	United States	90095
3	Ronald Reagan UCLA Medical Center, Drug Information Center	Los Angeles	California	United States	90095
4	UCLA Hematology & Oncology Clinic	Los Angeles	California	United States	90095
5	Santa Monica UCLA Hematology & Oncology Clinic	Santa Monica	California	United States	90404
6	Norton Cancer Institute, Multidisciplinary Clinic	Louisville	Kentucky	United States	40202
7	Norton Cancer Institute, Norton Healthcare Pavilion	Louisville	Kentucky	United States	40202
8	Norton Hospital	Louisville	Kentucky	United States	40202
9	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89169
10	University of Rochester	Rochester	New York	United States	14642
11	UNC Hospitals, The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7600
12	Tennessee Oncology, PLLC	Dickson	Tennessee	United States	37055
13	Tennessee Oncology, PLLC	Franklin	Tennessee	United States	37067
14	Tennessee Oncology, PLLC	Gallatin	Tennessee	United States	37066
15	Tennessee Oncology, PLLC	Hermitage	Tennessee	United States	37076
16	Tennessee Oncology, PLLC	Lebanon	Tennessee	United States	37090
17	Tennessee Oncology, PLLC	Murfreesboro	Tennessee	United States	37129
18	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37203
19	The Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
20	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37205
21	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37207
22	Tennessee Oncology, PLLC	Nashville	Tennessee	United States	37211
23	Tennessee Oncology, PLLC	Shelbyville	Tennessee	United States	37160
24	Tennessee Oncology, PLLC	Smyrna	Tennessee	United States	37167
25	MHAT Uni Hospital OOD	Panagyurishte	Pazardzhik	Bulgaria	4500
26	Complex Oncology Center - Plovdiv EOOD	Plovdiv		Bulgaria	4000
27	"MHAT for Women Health - Nadezhda" OOD	Sofia		Bulgaria	1330
28	SHATOD "Dr. Marko Antonov Markov - Varna" EOOD	Varna		Bulgaria	9002
29	National Cancer Center	Goyang-si	Gyeonggi-do	Korea, Republic of	10408
30	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
31	The Catholic University of Korea, St. Vincent's Hospital	Suwon	Gyeonggi-do	Korea, Republic of	16247
32	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
33	Division of Medical Oncology, Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
34	Severance Hospital Yonsei University Health System	Seoul		Korea, Republic of	03722
35	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
36	Asan Medical Center	Seoul		Korea, Republic of	05505
37	Ulsan University Hospital	Ulsan		Korea, Republic of	44033
38	Hospital Sultan Ismail	Johor Bahru	Johor	Malaysia	81100
39	University Malaya Medical Centre	Lembah Pantai	Kuala Lumpur	Malaysia	59100
40	Hospital Tengku Ampuan Afzan	Kuantan	Pahang	Malaysia	25100
41	Clinical Research Centre(Crc), Hospital Umum Sarawak	Kuching	Sarawak	Malaysia	93586
42	Szpitale Pomorskie Sp. z.o.o., Oddzial Onkologii i Radioterapii	Gdynia		Poland	81-519
43	Regionalny Szpital Specjalistyczny im. dr. Wl. Bieganskiego w Grudziadzu	Grudziadz		Poland	86-300
44	Centrum Badan Klinicznych JCI Life Science Park	Krakow		Poland	30-348
45	Mazowiecki Szpital Specjalistyczny im. Dr. Jozefa Psarskiego w Ostrolece, Osrodek Onkologiczny	Ostroleka		Poland	07-410
46	Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina	Otwock		Poland	05-400
47	Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie	Warszawa		Poland	02-781
48	Sbhi "Lrcod"	Vsevolozhsky District	Leningrad Region	Russian Federation	188663
49	SBHI ¨Saint-Petersburg clinical scientific practical center of specialized types of	Pesochny Village	Saint-petersburg	Russian Federation	197758
50	SBHI "ChRCCO and NM"	Chelyabinsk		Russian Federation	454087
51	MROI n.a. P.A. Gertsen, filiation of FSBI "NMRC of radiology" MoH Russia	Moscow		Russian Federation	125284
52	BHI of Omsk Region "Clinical Oncology Dispensary"	Omsk		Russian Federation	644013
53	Joint Stock Company Current medical technologies	Saint-Petersburg		Russian Federation	190013
54	Non-governmental Healthcare Institution ¨Railway Clinical Hospital of JSC ¨Russian Railways¨	Saint-Petersburg		Russian Federation	195271
55	SPb SBHI "City Clinical Oncology Dispensary"	Saint-Petersburg		Russian Federation	197022
56	SPb SBHI "City Clinical Oncology Dispensary"	Saint-Petersburg		Russian Federation	198255
57	Joint-Stock Company Current medical technologies	St. Petersburg		Russian Federation	190121
58	SBHI YaR ¨Regional clinical oncology hospital¨	Yaroslavl		Russian Federation	150054
59	Communal Non-profit Institution "City Clinical Hospital #4" of Dnipro City Council, Department of	Dnipro		Ukraine	49102
60	Communal non-Commercial Enterprise "Prykarpatski Clinical Oncological Center of Ivano-	Ivano-Frankivsk		Ukraine	79018
61	Grigoriev Radiological Institute of the National Academy of Medical Sciences of Ukraine,	Kharkiv		Ukraine	61024
62	Communal Non-profit Institution of Kharkiv Regional Council "Regional Clinical Specialized Health	Kharkiv		Ukraine	61166
63	"Specialized Clinic "Prognosis Optima" LLC	Kyiv		Ukraine	03126
64	Communal noncommercial enterprise Sumy regional Rada Sumy regional clinical oncologic dispensary,	Sumy		Ukraine	40030
65	Communal Non-profit Institution "Central City Clinical Hospital" of Uzhhorod City Council,	Uzhhorod		Ukraine	88000
66	Vinnytsia Regional Clinical Oncological Hospital	Vinnytsia		Ukraine	21029
67	Communal Institution ¨Zaporizhzhya Regional Clinical Oncological Dispensary¨	Zaporizhzhya		Ukraine	69040

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Aug 7, 2018
• Statistical Analysis Plan - Aug 24, 2020

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02573259
• Other Study ID Numbers: B8011001; 2016-003314-27
• First Posted: Oct 9, 2015
• Last Update Posted: Dec 13, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: efficacy; safety; pharmacokinetics; pharmacodynamics; open label; dose response; multiple ascending dose; immunogenicity; recommended phase 2 dose; subcutaneous
• Additional relevant MeSH terms: Carcinoma; Melanoma; Sarcoma; Head and Neck Neoplasms; Carcinoma, Transitional Cell

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	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
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Period Title: Overall Study
STARTED	2	8	8	7	15	68	39
Treated	2	8	8	7	15	68	38
COMPLETED	1	0	2	1	2	10	5
NOT COMPLETED	1	8	6	6	13	58	34

Baseline Characteristics

Arm/Group Title	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
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)	Total of all reporting groups
Overall Participants	2	8	8	7	15	68	38	146
Age, Customized (Number) [Number]
18-44 Years	0 0%	0 0%	1 12.5%	1 14.3%	0 0%	1 1.5%	1 2.6%	4 2.7%
45-64 Years	1 50%	3 37.5%	5 62.5%	3 42.9%	10 66.7%	28 41.2%	16 42.1%	66 45.2%
>=65 Years	1 50%	5 62.5%	2 25%	3 42.9%	5 33.3%	39 57.4%	21 55.3%	76 52.1%
Sex: Female, Male (Count of Participants)
Female	2 100%	6 75%	5 62.5%	4 57.1%	11 73.3%	15 22.1%	13 34.2%	56 38.4%
Male	0 0%	2 25%	3 37.5%	3 42.9%	4 26.7%	53 77.9%	25 65.8%	90 61.6%
Race/Ethnicity, Customized (Number) [Number]
White	2 100%	7 87.5%	7 87.5%	4 57.1%	12 80%	50 73.5%	30 78.9%	112 76.7%
Black or African American	0 0%	0 0%	0 0%	1 14.3%	2 13.3%	0 0%	0 0%	3 2.1%
Asian	0 0%	0 0%	0 0%	2 28.6%	1 6.7%	18 26.5%	8 21.1%	29 19.9%
Other	0 0%	1 12.5%	1 12.5%	0 0%	0 0%	0 0%	0 0%	2 1.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	8	8	7	15
Number [Percentage of Participants]	0 0%	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	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
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	2	8	8	7	15	68	38
Participants with AEs	2 100%	7 87.5%	8 100%	7 100%	15 100%	62 91.2%	36 94.7%
Participants with SAEs	1 50%	3 37.5%	3 37.5%	3 42.9%	3 20%	18 26.5%	13 34.2%
Participants with maximum Grade 3 or 4 AEs	2 100%	2 25%	3 37.5%	2 28.6%	4 26.7%	18 26.5%	13 34.2%
Participants with maximum Grade 5 AEs	0 0%	1 12.5%	1 12.5%	2 28.6%	0 0%	8 11.8%	5 13.2%

3. Primary Outcome

Title	Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	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
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	2	8	8	7	15	68	38
Participants with AEs	2 100%	6 75%	7 87.5%	6 85.7%	13 86.7%	42 61.8%	17 44.7%
Participants with SAEs	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	3 7.9%
Participants with maximum of Grade 3 or 4 AEs	1 50%	1 12.5%	1 12.5%	1 14.3%	1 6.7%	9 13.2%	5 13.2%
Participants with maximum of Grade 5 AEs	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants who received at least 1 dose of study medication.

Arm/Group Title	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
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	2	7	8	7	15	68	38
Grade 0	0 0%	2 25%	1 12.5%	1 14.3%	1 6.7%	16 23.5%	6 15.8%
Grade 1	1 50%	1 12.5%	4 50%	5 71.4%	5 33.3%	38 55.9%	16 42.1%
Grade 2	1 50%	4 50%	3 37.5%	1 14.3%	8 53.3%	13 19.1%	9 23.7%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 6.7%	1 1.5%	7 18.4%
Grade 4	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 0	2 100%	7 87.5%	8 100%	7 100%	15 100%	60 88.2%	35 92.1%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	7 10.3%	3 7.9%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 0	0 0%	3 37.5%	0 0%	1 14.3%	9 60%	27 39.7%	20 52.6%
Grade 1	0 0%	0 0%	2 25%	1 14.3%	2 13.3%	21 30.9%	11 28.9%
Grade 2	2 100%	2 25%	6 75%	4 57.1%	1 6.7%	15 22.1%	5 13.2%
Grade 3	0 0%	1 12.5%	0 0%	1 14.3%	3 20%	5 7.4%	2 5.3%
Grade 4	0 0%	1 12.5%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	2 100%	7 87.5%	8 100%	7 100%	14 93.3%	63 92.6%	37 97.4%
Grade 1	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 2	0 0%	0 0%	0 0%	0 0%	1 6.7%	5 7.4%	1 2.6%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 0	2 100%	6 75%	7 87.5%	5 71.4%	13 86.7%	61 89.7%	35 92.1%
Grade 1	0 0%	1 12.5%	1 12.5%	2 28.6%	1 6.7%	4 5.9%	0 0%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	2 2.9%	3 7.9%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	0 0%
Grade 0	1 50%	7 87.5%	7 87.5%	6 85.7%	12 80%	56 82.4%	33 86.8%
Grade 1	1 50%	0 0%	1 12.5%	1 14.3%	3 20%	12 17.6%	5 13.2%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 50%	5 62.5%	5 62.5%	3 42.9%	10 66.7%	62 91.2%	34 89.5%
Grade 1	1 50%	1 12.5%	3 37.5%	4 57.1%	4 26.7%	5 7.4%	3 7.9%
Grade 2	0 0%	1 12.5%	0 0%	0 0%	1 6.7%	0 0%	1 2.6%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	2 100%	7 87.5%	8 100%	4 57.1%	14 93.3%	45 66.2%	31 81.6%
Grade 1	0 0%	0 0%	0 0%	3 42.9%	1 6.7%	19 27.9%	3 7.9%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	3 7.9%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	3 4.4%	1 2.6%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 50%	4 50%	5 62.5%	4 57.1%	6 40%	36 52.9%	21 55.3%
Grade 1	0 0%	2 25%	3 37.5%	2 28.6%	7 46.7%	22 32.4%	11 28.9%
Grade 2	1 50%	1 12.5%	0 0%	0 0%	2 13.3%	7 10.3%	4 10.5%
Grade 3	0 0%	0 0%	0 0%	1 14.3%	0 0%	3 4.4%	2 5.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	5 62.5%	7 87.5%	5 71.4%	11 73.3%	44 64.7%	23 60.5%
Grade 1	2 100%	2 25%	1 12.5%	1 14.3%	4 26.7%	17 25%	13 34.2%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	5 7.4%	1 2.6%
Grade 3	0 0%	0 0%	0 0%	1 14.3%	0 0%	1 1.5%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.6%
Grade 0	1 50%	7 87.5%	7 87.5%	6 85.7%	13 86.7%	58 85.3%	34 89.5%
Grade 1	0 0%	0 0%	1 12.5%	0 0%	1 6.7%	6 8.8%	3 7.9%
Grade 2	1 50%	0 0%	0 0%	0 0%	1 6.7%	3 4.4%	1 2.6%
Grade 3	0 0%	0 0%	0 0%	1 14.3%	0 0%	1 1.5%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	3 150%
Grade 1	0 0%
Grade 2	0 0%
Grade 3	0 0%
Grade 4	0 0%
Grade 0	0 0%	0 0%	3 37.5%	0 0%	13 86.7%	58 85.3%	2 5.3%
Grade 1	1 50%	6 75%	4 50%	7 100%	1 6.7%	6 8.8%	30 78.9%
Grade 2	1 50%	1 12.5%	1 12.5%	0 0%	1 6.7%	3 4.4%	5 13.2%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	1 2.6%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	0 0%	0 0%
Grade 1	1 50%	2 25%	1 12.5%
Grade 2	0 0%	1 12.5%	0 0%
Grade 3	0 0%	1 12.5%	1 12.5%
Grade 4	0 0%	0 0%	0 0%
Grade 0	2 100%	7 87.5%	8 100%	7 100%	13 86.7%	51 75%	31 81.6%
Grade 1	0 0%	0 0%	0 0%	0 0%	1 6.7%	15 22.1%	5 13.2%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	2 5.3%
Grade 0	2 100%	5 62.5%	8 100%	6 85.7%	14 93.3%	24 35.3%	12 31.6%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	31 45.6%	21 55.3%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	10 14.7%	4 10.5%
Grade 3	0 0%	2 25%	0 0%	0 0%	1 6.7%	3 4.4%	1 2.6%
Grade 4	0 0%	0 0%	0 0%	1 14.3%	0 0%	0 0%	0 0%
Grade 0	2 100%	6 75%	7 87.5%	7 100%	15 100%	48 70.6%	27 71.1%
Grade 1	0 0%	0 0%	1 12.5%	0 0%	0 0%	8 11.8%	6 15.8%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	11 16.2%	3 7.9%
Grade 3	0 0%	1 12.5%	0 0%	0 0%	0 0%	1 1.5%	2 5.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 50%	7 87.5%	7 87.5%	5 71.4%	15 100%	55 80.9%	35 92.1%
Grade 1	1 50%	0 0%	1 12.5%	2 28.6%	0 0%	6 8.8%	3 7.9%
Grade 2	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	7 10.3%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	2 100%	5 62.5%	8 100%	6 85.7%	13 86.7%	51 75%	35 92.1%
Grade 1	0 0%	2 25%	0 0%	1 14.3%	2 13.3%	8 11.8%	2 5.3%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	7 10.3%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	2 2.9%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.6%
Grade 0	1 50%	5 62.5%	5 62.5%	3 42.9%	10 66.7%	40 58.8%	23 60.5%
Grade 1	0 0%	2 25%	2 25%	4 57.1%	2 13.3%	18 26.5%	11 28.9%
Grade 2	1 50%	0 0%	1 12.5%	0 0%	2 13.3%	10 14.7%	4 10.5%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	0 0%
Grade 4	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 0	1 50%	6 75%	5 62.5%	5 71.4%	13 86.7%	49 72.1%	30 78.9%
Grade 1	1 50%	1 12.5%	3 37.5%	2 28.6%	1 6.7%	12 17.6%	7 18.4%
Grade 2	0 0%	0 0%	0 0%	0 0%	1 6.7%	7 10.3%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.6%
Grade 0	2 100%	7 87.5%	8 100%	7 100%	15 100%	60 88.2%	32 84.2%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	8 11.8%	6 15.8%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 50%	7 87.5%	5 62.5%	6 85.7%	10 66.7%	61 89.7%	33 86.8%
Grade 1	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 2	1 50%	0 0%	3 37.5%	1 14.3%	4 26.7%	7 10.3%	3 7.9%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 6.7%	0 0%	2 5.3%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	2 100%	6 75%	7 87.5%	7 100%	8 53.3%	42 61.8%	29 76.3%
Grade 1	0 0%	1 12.5%	1 12.5%	0 0%	5 33.3%	14 20.6%	8 21.1%
Grade 2	0 0%	0 0%	0 0%	0 0%	2 13.3%	8 11.8%	1 2.6%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	4 5.9%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	4 50%	7 87.5%	5 71.4%	8 53.3%	45 66.2%	25 65.8%
Grade 1	0 0%	2 25%	1 12.5%	1 14.3%	5 33.3%	19 27.9%	10 26.3%
Grade 2	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 3	2 100%	0 0%	0 0%	1 14.3%	2 13.3%	3 4.4%	2 5.3%
Grade 4	0 0%	1 12.5%	0 0%	0 0%	0 0%	1 1.5%	1 2.6%
Grade 0	1 50%	5 62.5%	6 75%	7 100%	15 100%	56 82.4%	27 71.1%
Grade 1	0 0%	0 0%	0 0%	0 0%	0 0%	3 4.4%	7 18.4%
Grade 2	1 50%	2 25%	2 25%	0 0%	0 0%	7 10.3%	4 10.5%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	2 100%	4 50%	5 62.5%	7 100%	13 86.7%	50 73.5%	23 60.5%
Grade 1	0 0%	3 37.5%	1 12.5%	0 0%	0 0%	11 16.2%	7 18.4%
Grade 2	0 0%	0 0%	1 12.5%	0 0%	0 0%	4 5.9%	3 7.9%
Grade 3	0 0%	0 0%	1 12.5%	0 0%	1 6.7%	1 1.5%	3 7.9%
Grade 4	0 0%	0 0%	0 0%	0 0%	1 6.7%	2 2.9%	1 2.6%
Grade 0	1 50%	6 75%	7 87.5%	6 85.7%	13 86.7%	45 66.2%	23 60.5%
Grade 1	1 50%	1 12.5%	1 12.5%	0 0%	1 6.7%	16 23.5%	10 26.3%
Grade 2	0 0%	0 0%	0 0%	1 14.3%	0 0%	4 5.9%	2 5.3%
Grade 3	0 0%	0 0%	0 0%	0 0%	1 6.7%	3 4.4%	3 7.9%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	0 0%	5 62.5%	4 50%	1 14.3%	9 60%	46 67.6%	15 39.5%
Grade 1	1 50%	2 25%	3 37.5%	3 42.9%	6 40%	15 22.1%	17 44.7%
Grade 2	1 50%	0 0%	1 12.5%	2 28.6%	0 0%	5 7.4%	5 13.2%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 2.6%
Grade 4	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 0	1 50%	6 75%	5 62.5%	4 57.1%	11 73.3%	44 64.7%	19 50%
Grade 1	1 50%	1 12.5%	3 37.5%	3 42.9%	4 26.7%	19 27.9%	15 39.5%
Grade 2	0 0%	0 0%	0 0%	0 0%	0 0%	4 5.9%	3 7.9%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.5%	1 2.6%
Grade 4	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN
Grade 0	2 100%	5 62.5%	6 75%	4 57.1%	12 80%	39 57.4%	31 81.6%
Grade 1	0 0%	2 25%	1 12.5%	3 42.9%	3 20%	25 36.8%	4 10.5%
Grade 2	0 0%	0 0%	1 12.5%	0 0%	0 0%	1 1.5%	1 2.6%
Grade 3	0 0%	0 0%	0 0%	0 0%	0 0%	3 4.4%	0 0%
Grade 4	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN	NA NaN

5. Primary Outcome

Title	Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 2: PF-06801591 300 mg (SC) for NSCLC	Part 2: PF-06801591 300 mg (SC) for UC
Arm/Group Description	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	67	38
Number (95% Confidence Interval) [Percentage]	16.4	18.4

6. Primary Outcome

Title	Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 2: PF-06801591 300 mg (SC) for NSCLC	Part 2: PF-06801591 300 mg (SC) for UC
Arm/Group Description	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	67	38
Number (95% Confidence Interval) [Percentage of Participants]	19.4 970%	21.1 263.8%

7. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants treated who were evaluable for this outcome measure.

Arm/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	8	8	7	15
Cycle 1 Day 1	NA (NA)	21.52 (23)	69.63 (28)	217.2 (36)	21.24 (50)
Cycle 4 Day 1	NA (NA)	30.10 (16)	86.34 (52)	402.6 (42)	56.48 (29)

8. Secondary Outcome

Title	AUClast of PF-06801591 in Part 1.
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants treated who were evaluable for this outcome measure.

Arm/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	7	7	7	15
Geometric Mean (Geometric Coefficient of Variation) [ug*hr/mL]	NA (NA)	4700 (41)	14770 (27)	46780 (49)	9923 (65)

9. Secondary Outcome

Title	Clearance (CL) of PF-06801591 - Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants treated who were evaluable for this outcome measure.

Arm/Group Title	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)
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Measure Participants	2	2	3	4
Cycle 1 Day 1	NA (NA)
Cycle 4 Day 1	NA (NA)	NA (NA)	0.006045 (57)	0.004984 (14)

10. Secondary Outcome

Title	Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	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)
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Measure Participants	2	8	8	7
Cycle 1 Day 1	NA (NA)

11. Secondary Outcome

Title	Accumulation Ratio (Rac) of PF-06801591 - Part 1
Description	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

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants treated who were evaluable for this outcome measure.

Arm/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	2	2	4	3
Geometric Mean (Geometric Coefficient of Variation) [Ratio]	NA (NA)	NA (NA)	NA (NA)	2.360 (12)	2.073 (31)

12. Secondary Outcome

Title	Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	8	8	7	15
Cycle 1 Day 1	NA (NA)
Cycle 4 Day 1	NA (NA)

13. Secondary Outcome

Title	Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result.

Arm/Group Title	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	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)
Arm/Group Description	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Measure Participants	14	64	37	2	6	7	6
Count of Participants [Participants]	1 50%	5 62.5%	3 37.5%	1 14.3%	1 6.7%	0 0%	0 0%

14. Secondary Outcome

Title	Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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	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)
Arm/Group Description	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Measure Participants	14	64	37	2	6	7	6
Count of Participants [Participants]	0 0%	3 37.5%	1 12.5%	0 0%	0 0%	0 0%	0 0%

15. Secondary Outcome

Title	Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1
Description	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)

Outcome Measure Data

Analysis Population Description

Analysis population included all enrolled participants with at least 1 of the pharmacodynamic/biomarker parameters evaluated at pre- and/or post dose.

Arm/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	8	7	7	15
Cycle 1 Day 1	0.00	0.00	0.56	0.02	0.32
Cycle 1 Day 8	0.00	0.00	0.00	0.00	0.00
Cycle 1 Day 15	0.00	0.00	0.00	0.00	0.57
Cycle 1 Day 21	0.00
Cycle 2 Day 1	1.48	0.04	0.82	0.00	0.00
Cycle 3 Day 1	0.00	0.00	0.47	0.00	0.00
Cycle 4 Day 1	0.80	0.00	0.05	0.00	0.00
Cycle 4 Day 15	0.00	0.00	0.00	0.00	0.00
Cycle 4 Day 21	1.31
Cycle 5 Day 1	0.00	0.00	0.00	0.00	0.00
EOT	0.00	0.00	0.00	0.17

16. Secondary Outcome

Title	Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	7	8	7	15
Count of Participants [Participants]	1 50%	2 25%	1 12.5%	2 28.6%	1 6.7%

17. Secondary Outcome

Title	Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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])
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Measure Participants	2	7	8	7	15
Count of Participants [Participants]	1 50%	2 25%	1 12.5%	2 28.6%	1 6.7%

18. Secondary Outcome

Title	Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [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
Arm/Group Description	This was a combined group of PF-06801591 0.5, 1, 3, and 10 mg/kg (IV) in Part 1. Participants received PF-06801591 0.5, 1, 3, or 10 mg/kg IV every 3 weeks for 21-day cycles. (up to a maximum of 233 weeks).	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	24	15	67	38
RECIST v1.1	4.7	3.0	3.7	2.9
irRECIST	4.9	4.5	5.5	3.8

19. Secondary Outcome

Title	Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	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
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)	Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)	Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)	Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	1	2	3	2	5	24	12
RECIST v1.1	NA	NA	24.3	5.7	6.0	6.5	8.5
irRECIST	NA	NA	29.0	5.7	13.7	7.5	14.5

20. Secondary Outcome

Title	Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [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
Arm/Group Description	This was a combined group of PF-06801591 0.5, 1, 3, and 10 mg/kg (IV) in Part 1. Participants received PF-06801591 0.5, 1, 3, or 10 mg/kg IV every 3 weeks for 21-day cycles. (up to a maximum of 233 weeks).	Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	6	1	13	8
RECIST v1.1	9.7	NA	21.8	13.9
irRECIST	13.0	NA	22.1	NA

21. Secondary Outcome

Title	Time to Response (TTR) Based on RECIST Version 1.1 - Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 2: PF-06801591 300 mg (SC) for NSCLC	Part 2: PF-06801591 300 mg (SC) for UC
Arm/Group Description	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	14	8
Median (Full Range) [Months]	2.71	2.33

22. Secondary Outcome

Title	Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 2: PF-06801591 300 mg (SC) for NSCLC	Part 2: PF-06801591 300 mg (SC) for UC
Arm/Group Description	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	67	38
RECIST v1.1	3.7	3.7
irRECIST	6.5	8.5

23. Secondary Outcome

Title	Median Time to Death - Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 2: PF-06801591 300 mg (SC) for NSCLC	Part 2: PF-06801591 300 mg (SC) for UC
Arm/Group Description	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	68	39
Median (95% Confidence Interval) [Months]	14.7	10.9

24. Secondary Outcome

Title	Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 2: PF-06801591 300 mg (SC) for NSCLC	Part 2: PF-06801591 300 mg (SC) for UC
Arm/Group Description	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	68	39
6 Months	0.773	0.711
1 Year	0.547	0.471
2 Years	0.403	0.286

25. Secondary Outcome

Title	Trough PF-06801591 Concentrations (Ctrough) - Part 2
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Part 2: PF-06801591 300 mg (SC) for NSCLC	Part 2: PF-06801591 300 mg (SC) for UC
Arm/Group Description	Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)	Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Measure Participants	68	39
Cycle 2 Day 1	14.97 (48)	14.34 (73)
Cycle 3 Day 1	22.54 (37)	20.15 (84)
Cycle 4 Day 1	23.55 (53)	23.77 (60)
Cycle 5 Day 1	23.58 (41)	19.32 (186)
Cycle 6 Day 1	29.67 (36)	17.13 (249)
Cycle 9 Day 1	29.01 (36)	29.88 (30)
Cycle 12 Day 1	34.29 (16)	12.74 (770)
Cycle 15 Day 1	40.90 (22)	22.10 (56)
Cycle 18 Day 1	35.09 (25)	20.17 (75)
Cycle 21 Day 1	27.16 (25)	22.11 (55)
Cycle 24 Day 1	30.81 (16)	38.02 (38)
Follow-up Day 28	43.62 (33)	35.17 (32)

Adverse Events

Time Frame	Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).
Adverse Event Reporting Description	The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Arm/Group Title	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 1: PF-06801591 IV Total		Part 1: PF-06801591 IV and SC Total		Part 2: PF-06801591 300 mg (SC) for NSCLC		Part 2: PF-06801591 300 mg (SC) for UC		Part 2: PF-06801591 NSCLC and UC Total
Arm/Group Description	Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)		Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)		Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)		Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)		Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)		Participants received PF-06801591 IV every 3 weeks for 21-day cycles in Part 1. (up to a maximum of of 233 weeks)		Participants received PF-06801591 IV every 3 weeks for 21-day cycles or SC every 4 weeks for 28-day cycles in Part 1. (up to a maximum of 233 weeks)		Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)		Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)		Participants with NSCLC or UC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles in Part 2. (up to a maximum of 126 weeks)
All Cause Mortality
	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 1: PF-06801591 IV Total		Part 1: PF-06801591 IV and SC Total		Part 2: PF-06801591 300 mg (SC) for NSCLC		Part 2: PF-06801591 300 mg (SC) for UC		Part 2: PF-06801591 NSCLC and UC Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		6/8 (75%)		5/8 (62.5%)		6/7 (85.7%)		10/15 (66.7%)		18/25 (72%)		28/40 (70%)		33/68 (48.5%)		21/38 (55.3%)		54/106 (50.9%)
Serious Adverse Events
	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 1: PF-06801591 IV Total		Part 1: PF-06801591 IV and SC Total		Part 2: PF-06801591 300 mg (SC) for NSCLC		Part 2: PF-06801591 300 mg (SC) for UC		Part 2: PF-06801591 NSCLC and UC Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		3/8 (37.5%)		3/8 (37.5%)		3/7 (42.9%)		3/15 (20%)		10/25 (40%)		13/40 (32.5%)		18/68 (26.5%)		13/38 (34.2%)		31/106 (29.2%)
Blood and lymphatic system disorders
Anaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
Cardiac disorders
Arrhythmia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Atrial fibrillation	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Cardiac failure	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Cardiogenic shock	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Gastrointestinal disorders
Diarrhoea	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Dysphagia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Enteritis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Gastric ulcer haemorrhage	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Intestinal obstruction	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Small intestinal obstruction	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Upper gastrointestinal haemorrhage	1/2 (50%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
General disorders
Disease progression	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		2/7 (28.6%)		0/15 (0%)		4/25 (16%)		4/40 (10%)		3/68 (4.4%)		2/38 (5.3%)		5/106 (4.7%)
Mucosal ulceration	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Multiple organ dysfunction syndrome	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Non-cardiac chest pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Infections and infestations
Bronchitis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Pneumonia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Postoperative wound infection	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Pyelonephritis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Sepsis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Urinary tract infection	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Urosepsis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Injury, poisoning and procedural complications
Skin laceration	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Investigations
Transaminases increased	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Metabolism and nutrition disorders
Dehydration	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Musculoskeletal and connective tissue disorders
Muscular weakness	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Rotator cuff syndrome	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Lung neoplasm malignant	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Neoplasm progression	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Nervous system disorders
Cerebral infarction	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Cognitive disorder	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Spinal cord compression	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Renal and urinary disorders
Acute kidney injury	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Hydronephrosis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Haemoptysis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Hypoxia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Pneumonitis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Pneumothorax	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Pulmonary embolism	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Other (Not Including Serious) Adverse Events
	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 1: PF-06801591 IV Total		Part 1: PF-06801591 IV and SC Total		Part 2: PF-06801591 300 mg (SC) for NSCLC		Part 2: PF-06801591 300 mg (SC) for UC		Part 2: PF-06801591 NSCLC and UC Total
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		7/8 (87.5%)		8/8 (100%)		7/7 (100%)		15/15 (100%)		24/25 (96%)		39/40 (97.5%)		59/68 (86.8%)		33/38 (86.8%)		92/106 (86.8%)
Blood and lymphatic system disorders
Anaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		13/68 (19.1%)		12/38 (31.6%)		25/106 (23.6%)
Cardiac disorders
Atrial fibrillation	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		3/68 (4.4%)		0/38 (0%)		3/106 (2.8%)
Bundle branch block	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Cardiac arrest	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Myocardial ischaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Palpitations	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Tachycardia	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Ear and labyrinth disorders
Ear pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		2/7 (28.6%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Tinnitus	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Endocrine disorders
Hyperthyroidism	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		8/68 (11.8%)		3/38 (7.9%)		11/106 (10.4%)
Hypothyroidism	1/2 (50%)		1/8 (12.5%)		0/8 (0%)		1/7 (14.3%)		1/15 (6.7%)		3/25 (12%)		4/40 (10%)		5/68 (7.4%)		4/38 (10.5%)		9/106 (8.5%)
Eye disorders
Conjunctival haemorrhage	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Eye swelling	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Lacrimation increased	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
Punctate keratitis	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Vision blurred	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Gastrointestinal disorders
Abdominal discomfort	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Abdominal distension	1/2 (50%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Abdominal pain	1/2 (50%)		0/8 (0%)		2/8 (25%)		1/7 (14.3%)		1/15 (6.7%)		4/25 (16%)		5/40 (12.5%)		1/68 (1.5%)		2/38 (5.3%)		3/106 (2.8%)
Abdominal pain lower	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
Abdominal pain upper	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Constipation	2/2 (100%)		4/8 (50%)		2/8 (25%)		3/7 (42.9%)		2/15 (13.3%)		11/25 (44%)		13/40 (32.5%)		2/68 (2.9%)		4/38 (10.5%)		6/106 (5.7%)
Diarrhoea	1/2 (50%)		2/8 (25%)		3/8 (37.5%)		2/7 (28.6%)		4/15 (26.7%)		8/25 (32%)		12/40 (30%)		4/68 (5.9%)		5/38 (13.2%)		9/106 (8.5%)
Dry mouth	1/2 (50%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		2/15 (13.3%)		2/25 (8%)		4/40 (10%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Duodenitis	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Dyspepsia	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Dysphagia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Enterocolitis	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Epigastric discomfort	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Faeces discoloured	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Flatulence	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Gastrointestinal pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Gingival pain	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Glossodynia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Haemorrhoids	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Impaired gastric emptying	1/2 (50%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		1/15 (6.7%)		2/25 (8%)		3/40 (7.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Intestinal obstruction	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Nausea	2/2 (100%)		1/8 (12.5%)		3/8 (37.5%)		0/7 (0%)		6/15 (40%)		6/25 (24%)		12/40 (30%)		5/68 (7.4%)		3/38 (7.9%)		8/106 (7.5%)
Oesophagitis	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Oral pain	1/2 (50%)		0/8 (0%)		1/8 (12.5%)		1/7 (14.3%)		1/15 (6.7%)		3/25 (12%)		4/40 (10%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Pancreatic failure	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Paraesthesia oral	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Salivary duct inflammation	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Small intestinal obstruction	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Tongue ulceration	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Vomiting	2/2 (100%)		2/8 (25%)		2/8 (25%)		1/7 (14.3%)		5/15 (33.3%)		7/25 (28%)		12/40 (30%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
General disorders
Asthenia	1/2 (50%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		7/68 (10.3%)		6/38 (15.8%)		13/106 (12.3%)
Chest discomfort	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		2/68 (2.9%)		0/38 (0%)		2/106 (1.9%)
Chest pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		4/68 (5.9%)		0/38 (0%)		4/106 (3.8%)
Chills	0/2 (0%)		0/8 (0%)		0/8 (0%)		2/7 (28.6%)		1/15 (6.7%)		2/25 (8%)		3/40 (7.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Fatigue	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		2/15 (13.3%)		1/25 (4%)		3/40 (7.5%)		8/68 (11.8%)		3/38 (7.9%)		11/106 (10.4%)
Generalised oedema	2/2 (100%)		3/8 (37.5%)		4/8 (50%)		4/7 (57.1%)		5/15 (33.3%)		13/25 (52%)		18/40 (45%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Influenza like illness	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		1/68 (1.5%)		2/38 (5.3%)		3/106 (2.8%)
Injection site pain	0/2 (0%)		0/8 (0%)		2/8 (25%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Localised oedema	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Malaise	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Mucosal inflammation	2/2 (100%)		1/8 (12.5%)		0/8 (0%)		1/7 (14.3%)		1/15 (6.7%)		4/25 (16%)		5/40 (12.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Non-cardiac chest pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Oedema	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Oedema peripheral	1/2 (50%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		3/68 (4.4%)		2/38 (5.3%)		5/106 (4.7%)
Pain	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Pyrexia	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		8/68 (11.8%)		3/38 (7.9%)		11/106 (10.4%)
Systemic inflammatory response syndrome	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Hepatobiliary disorders
Hepatomegaly	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Hyperbilirubinaemia	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Jaundice	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Ocular icterus	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Portal hypertension	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Infections and infestations
Bronchitis	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Candida infection	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		3/15 (20%)		0/25 (0%)		3/40 (7.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Fungal skin infection	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Gastroenteritis	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Influenza	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		1/7 (14.3%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Nasopharyngitis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
Oral candidiasis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Oral herpes	0/2 (0%)		2/8 (25%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Sepsis	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Sinusitis	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		1/7 (14.3%)		1/15 (6.7%)		2/25 (8%)		3/40 (7.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Tooth infection	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Upper respiratory tract infection	0/2 (0%)		0/8 (0%)		2/8 (25%)		1/7 (14.3%)		3/15 (20%)		3/25 (12%)		6/40 (15%)		2/68 (2.9%)		2/38 (5.3%)		4/106 (3.8%)
Urinary tract infection	2/2 (100%)		0/8 (0%)		1/8 (12.5%)		1/7 (14.3%)		2/15 (13.3%)		4/25 (16%)		6/40 (15%)		2/68 (2.9%)		5/38 (13.2%)		7/106 (6.6%)
Injury, poisoning and procedural complications
Cervical vertebral fracture	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Contusion	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Eye contusion	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Eye injury	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Fall	0/2 (0%)		0/8 (0%)		2/8 (25%)		0/7 (0%)		1/15 (6.7%)		2/25 (8%)		3/40 (7.5%)		2/68 (2.9%)		2/38 (5.3%)		4/106 (3.8%)
Wound	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Wound dehiscence	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Investigations
Alanine aminotransferase increased	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		8/68 (11.8%)		2/38 (5.3%)		10/106 (9.4%)
Amylase increased	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		6/68 (8.8%)		4/38 (10.5%)		10/106 (9.4%)
Aspartate aminotransferase	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Aspartate aminotransferase increased	1/2 (50%)		0/8 (0%)		1/8 (12.5%)		2/7 (28.6%)		1/15 (6.7%)		4/25 (16%)		5/40 (12.5%)		7/68 (10.3%)		2/38 (5.3%)		9/106 (8.5%)
Blood albumin decreased	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Blood alkaline phosphatase abnormal	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Blood alkaline phosphatase increased	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		5/68 (7.4%)		2/38 (5.3%)		7/106 (6.6%)
Blood bilirubin increased	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		5/68 (7.4%)		0/38 (0%)		5/106 (4.7%)
Blood creatinine increased	2/2 (100%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		2/15 (13.3%)		4/25 (16%)		6/40 (15%)		3/68 (4.4%)		3/38 (7.9%)		6/106 (5.7%)
Blood lactate dehydrogenase increased	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		2/68 (2.9%)		0/38 (0%)		2/106 (1.9%)
Blood magnesium increased	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Blood phosphorus decreased	1/2 (50%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Blood sodium decreased	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Blood thyroid stimulating hormone increased	0/2 (0%)		0/8 (0%)		3/8 (37.5%)		0/7 (0%)		1/15 (6.7%)		3/25 (12%)		4/40 (10%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Body temperature increased	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		5/68 (7.4%)		1/38 (2.6%)		6/106 (5.7%)
Breath sounds abnormal	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Cardiac murmur	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Electrocardiogram QT prolonged	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Electrocardiogram ST segment depression	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Eosinophil count increased	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Haemoglobin decreased	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Lipase increased	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		5/68 (7.4%)		4/38 (10.5%)		9/106 (8.5%)
Neutrophil count decreased	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Platelet count decreased	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		3/68 (4.4%)		1/38 (2.6%)		4/106 (3.8%)
Weight decreased	1/2 (50%)		0/8 (0%)		1/8 (12.5%)		1/7 (14.3%)		2/15 (13.3%)		3/25 (12%)		5/40 (12.5%)		4/68 (5.9%)		2/38 (5.3%)		6/106 (5.7%)
Weight increased	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
White blood cell count decreased	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/2 (100%)		3/8 (37.5%)		1/8 (12.5%)		0/7 (0%)		7/15 (46.7%)		6/25 (24%)		13/40 (32.5%)		9/68 (13.2%)		3/38 (7.9%)		12/106 (11.3%)
Dehydration	1/2 (50%)		1/8 (12.5%)		1/8 (12.5%)		1/7 (14.3%)		3/15 (20%)		4/25 (16%)		7/40 (17.5%)		2/68 (2.9%)		1/38 (2.6%)		3/106 (2.8%)
Fluid overload	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Hyperammonaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Hypercalcaemia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		3/68 (4.4%)		3/38 (7.9%)		6/106 (5.7%)
Hyperglycaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Hyperkalaemia	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Hypermagnesaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		4/68 (5.9%)		0/38 (0%)		4/106 (3.8%)
Hyperuricaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		2/68 (2.9%)		0/38 (0%)		2/106 (1.9%)
Hypoalbuminaemia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		4/68 (5.9%)		1/38 (2.6%)		5/106 (4.7%)
Hypocalcaemia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		2/68 (2.9%)		0/38 (0%)		2/106 (1.9%)
Hypokalaemia	1/2 (50%)		0/8 (0%)		2/8 (25%)		0/7 (0%)		3/15 (20%)		3/25 (12%)		6/40 (15%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Hypomagnesaemia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		2/15 (13.3%)		1/25 (4%)		3/40 (7.5%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
Hyponatraemia	1/2 (50%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		2/68 (2.9%)		1/38 (2.6%)		3/106 (2.8%)
Hypophosphataemia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Hypovolaemia	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Increased appetite	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/2 (50%)		1/8 (12.5%)		3/8 (37.5%)		1/7 (14.3%)		2/15 (13.3%)		6/25 (24%)		8/40 (20%)		4/68 (5.9%)		4/38 (10.5%)		8/106 (7.5%)
Back pain	2/2 (100%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		4/15 (26.7%)		4/25 (16%)		8/40 (20%)		3/68 (4.4%)		6/38 (15.8%)		9/106 (8.5%)
Bone pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Flank pain	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
Foot deformity	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Groin pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Muscle spasms	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Myalgia	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Pain in extremity	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		2/68 (2.9%)		2/38 (5.3%)		4/106 (3.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Tumour pain	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Nervous system disorders
Balance disorder	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Burning sensation	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Disturbance in attention	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Dizziness	1/2 (50%)		2/8 (25%)		1/8 (12.5%)		1/7 (14.3%)		0/15 (0%)		5/25 (20%)		5/40 (12.5%)		3/68 (4.4%)		1/38 (2.6%)		4/106 (3.8%)
Dysarthria	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Dysgeusia	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Headache	1/2 (50%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		1/15 (6.7%)		3/25 (12%)		4/40 (10%)		3/68 (4.4%)		2/38 (5.3%)		5/106 (4.7%)
Memory impairment	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Neuralgia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Neuropathy peripheral	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Paraesthesia	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Peripheral sensory neuropathy	0/2 (0%)		1/8 (12.5%)		2/8 (25%)		0/7 (0%)		0/15 (0%)		3/25 (12%)		3/40 (7.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Syncope	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Taste disorder	1/2 (50%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Tremor	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Psychiatric disorders
Anxiety	1/2 (50%)		2/8 (25%)		0/8 (0%)		0/7 (0%)		3/15 (20%)		3/25 (12%)		6/40 (15%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Confusional state	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Depression	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		2/68 (2.9%)		0/38 (0%)		2/106 (1.9%)
Insomnia	1/2 (50%)		0/8 (0%)		1/8 (12.5%)		1/7 (14.3%)		1/15 (6.7%)		3/25 (12%)		4/40 (10%)		6/68 (8.8%)		0/38 (0%)		6/106 (5.7%)
Mental status changes	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Renal and urinary disorders
Acute kidney injury	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		2/38 (5.3%)		2/106 (1.9%)
Dysuria	1/2 (50%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Haematuria	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		2/68 (2.9%)		2/38 (5.3%)		4/106 (3.8%)
Hypertonic bladder	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Pollakiuria	1/2 (50%)		2/8 (25%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		3/25 (12%)		3/40 (7.5%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Proteinuria	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		1/7 (14.3%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		4/68 (5.9%)		2/38 (5.3%)		6/106 (5.7%)
Urinary tract pain	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Reproductive system and breast disorders
Breast pain	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Erectile dysfunction	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Respiratory, thoracic and mediastinal disorders
Cough	1/2 (50%)		1/8 (12.5%)		3/8 (37.5%)		1/7 (14.3%)		4/15 (26.7%)		6/25 (24%)		10/40 (25%)		6/68 (8.8%)		2/38 (5.3%)		8/106 (7.5%)
Diaphragmalgia	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Dyspnoea	1/2 (50%)		1/8 (12.5%)		2/8 (25%)		2/7 (28.6%)		5/15 (33.3%)		6/25 (24%)		11/40 (27.5%)		10/68 (14.7%)		0/38 (0%)		10/106 (9.4%)
Dyspnoea exertional	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		1/68 (1.5%)		2/38 (5.3%)		3/106 (2.8%)
Haemoptysis	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		4/68 (5.9%)		0/38 (0%)		4/106 (3.8%)
Hypoxia	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Nasal congestion	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Oropharyngeal pain	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		2/7 (28.6%)		1/15 (6.7%)		3/25 (12%)		4/40 (10%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Orthopnoea	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Pleural effusion	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		0/25 (0%)		0/40 (0%)		4/68 (5.9%)		1/38 (2.6%)		5/106 (4.7%)
Pleuritic pain	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Pneumonia aspiration	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Pneumonitis	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		4/68 (5.9%)		0/38 (0%)		4/106 (3.8%)
Pneumothorax	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Productive cough	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		7/68 (10.3%)		1/38 (2.6%)		8/106 (7.5%)
Rhinitis allergic	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Rhinorrhoea	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		0/38 (0%)		1/106 (0.9%)
Sinus congestion	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Sneezing	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Sputum discoloured	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Upper-airway cough syndrome	1/2 (50%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Wheezing	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Skin and subcutaneous tissue disorders
Dermatitis bullous	0/2 (0%)		1/8 (12.5%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Dry skin	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		1/68 (1.5%)		2/38 (5.3%)		3/106 (2.8%)
Hyperhidrosis	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		1/68 (1.5%)		1/38 (2.6%)		2/106 (1.9%)
Night sweats	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Pruritus	1/2 (50%)		0/8 (0%)		1/8 (12.5%)		2/7 (28.6%)		0/15 (0%)		4/25 (16%)		4/40 (10%)		8/68 (11.8%)		4/38 (10.5%)		12/106 (11.3%)
Rash	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		5/68 (7.4%)		2/38 (5.3%)		7/106 (6.6%)
Rash maculo-papular	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Skin disorder	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Vascular disorders
Deep vein thrombosis	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Flushing	0/2 (0%)		0/8 (0%)		1/8 (12.5%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Hot flush	0/2 (0%)		0/8 (0%)		2/8 (25%)		0/7 (0%)		0/15 (0%)		2/25 (8%)		2/40 (5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Hypertension	0/2 (0%)		0/8 (0%)		0/8 (0%)		1/7 (14.3%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		2/68 (2.9%)		1/38 (2.6%)		3/106 (2.8%)
Hypotension	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		1/25 (4%)		2/40 (5%)		2/68 (2.9%)		1/38 (2.6%)		3/106 (2.8%)
Lymphoedema	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		1/38 (2.6%)		1/106 (0.9%)
Peripheral embolism	0/2 (0%)		0/8 (0%)		0/8 (0%)		0/7 (0%)		1/15 (6.7%)		0/25 (0%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)
Shock	0/2 (0%)		1/8 (12.5%)		0/8 (0%)		0/7 (0%)		0/15 (0%)		1/25 (4%)		1/40 (2.5%)		0/68 (0%)		0/38 (0%)		0/106 (0%)

Limitations/Caveats

[Not Specified]

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