Trial Outcomes & Findings for A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy (NCT NCT01712061)

NCT ID: NCT01712061

Last Updated: 2015-10-21

Results Overview

The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

226 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2015-10-21

Participant Flow

The primary entry criterion for participants was based on presence of macroalbuminuria (urine albumin to creatinine ratio \[UACR\] greater than or equal to (\>=)300 milligrams per gram (mg/g).

Participant milestones

Participant milestones
Measure	PF-04634817 150 mg Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (\<)30 milliliters/minute (mL/min)/1.73 square meter (m\^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.	PF-04634817 200 mg Participants with eGFR values of 30 to 75 mL/min/1.73 m\^2 were dosed orally at 200 mg QD for 12 weeks.	Placebo Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Overall Study STARTED	30	140	56
Overall Study COMPLETED	20	114	45
Overall Study NOT COMPLETED	10	26	11

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-04634817 150 mg Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (\<)30 milliliters/minute (mL/min)/1.73 square meter (m\^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.	PF-04634817 200 mg Participants with eGFR values of 30 to 75 mL/min/1.73 m\^2 were dosed orally at 200 mg QD for 12 weeks.	Placebo Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Overall Study Adverse Event	4	9	5
Overall Study Death	0	0	1
Overall Study Lost to Follow-up	1	0	1
Overall Study Did Not Meet Entrance Criteria	4	6	3
Overall Study Medication Error Without Associated AE	0	1	0
Overall Study Withdrawal by Subject	1	7	1
Overall Study Other	0	3	0

Baseline Characteristics

A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-04634817 200 mg/150 mg n=170 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=56 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.	Total n=226 Participants Total of all reporting groups
Age, Customized Less than (<) 18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized 18-44 years	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Age, Customized 45-64 years	78 participants n=5 Participants	31 participants n=7 Participants	109 participants n=5 Participants
Age, Customized >=65 years	89 participants n=5 Participants	25 participants n=7 Participants	114 participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	7 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	134 Participants n=5 Participants	49 Participants n=7 Participants	183 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.

The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12	13.27 percent (%) 95% Confidence Interval 5.43 • Interval 3.14 to 24.62	5.02 percent (%) 95% Confidence Interval 6.87 • Interval -7.9 to 18.7

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8 and 16

Population: The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.

The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in UACR at Weeks 4, 8 and 16 Baseline (n=157,50)	127.41 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 96	121.80 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 88
Change From Baseline in UACR at Weeks 4, 8 and 16 Change From Baseline at Week 4 (n=148,46)	0.89 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 66	0.91 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 88
Change From Baseline in UACR at Weeks 4, 8 and 16 Change From Baseline at Week 8 (n=134,43)	0.90 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 62	0.94 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 57
Change From Baseline in UACR at Weeks 4, 8 and 16 Change From Baseline at Week 16 (n=126,37)	0.93 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 72	0.92 mg/millimolar creatinine (mmolCr) Geometric Coefficient of Variation 56

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 16

The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 Baseline (n=155,49)	185.42 mg/mmolCr Geometric Coefficient of Variation 97	176.31 mg/mmolCr Geometric Coefficient of Variation 82
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 4 (n=143,45)	0.93 mg/mmolCr Geometric Coefficient of Variation 47	0.92 mg/mmolCr Geometric Coefficient of Variation 76
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 8 (n=130,42)	0.92 mg/mmolCr Geometric Coefficient of Variation 50	0.94 mg/mmolCr Geometric Coefficient of Variation 46
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 12 (n=125,42)	0.92 mg/mmolCr Geometric Coefficient of Variation 58	0.92 mg/mmolCr Geometric Coefficient of Variation 79
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 16 (n=125,36)	0.95 mg/mmolCr Geometric Coefficient of Variation 58	0.92 mg/mmolCr Geometric Coefficient of Variation 55

SECONDARY outcome

Timeframe: Baseline, Week 1, 4, 8, 12 and 16

eGFR was calculated using the MDRD equation and normalized to 1.73 m\^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 16 (n=134,44)	-2.14 mL/min/1.73m^2 Standard Deviation 6.42	-1.18 mL/min/1.73m^2 Standard Deviation 5.58
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 Baseline (n=159,51)	41.80 mL/min/1.73m^2 Standard Deviation 12.18	41.65 mL/min/1.73m^2 Standard Deviation 13.46
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 1 (n=157,50)	-0.77 mL/min/1.73m^2 Standard Deviation 5.80	-0.35 mL/min/1.73m^2 Standard Deviation 5.28
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 4 (n=157,51)	-1.07 mL/min/1.73m^2 Standard Deviation 5.37	-1.32 mL/min/1.73m^2 Standard Deviation 5.12
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 8 (n=147,47)	-1.60 mL/min/1.73m^2 Standard Deviation 5.34	-2.15 mL/min/1.73m^2 Standard Deviation 6.83
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 12 (n=136,45)	-1.14 mL/min/1.73m^2 Standard Deviation 5.70	-1.03 mL/min/1.73m^2 Standard Deviation 5.75

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 16

Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m\^2 body surface area.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16 Baseline (n=159,50)	45.28 mL/min/1.73m^2 Standard Deviation 14.22	45.36 mL/min/1.73m^2 Standard Deviation 14.94
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16 Change From Baseline at Week 12 (n=135,44)	-1.10 mL/min/1.73m^2 Standard Deviation 6.30	-0.70 mL/min/1.73m^2 Standard Deviation 5.49
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16 Change From Baseline at Week 16 (n=134,43)	-2.27 mL/min/1.73m^2 Standard Deviation 6.77	-0.91 mL/min/1.73m^2 Standard Deviation 6.30

SECONDARY outcome

Timeframe: Baseline, Week 1, 4, 8, 12 and 16

Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 1 (n=158,50)	0.05 milligrams per deciliter (mg/dL) Standard Deviation 0.22	0.03 milligrams per deciliter (mg/dL) Standard Deviation 0.17
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 12 (n=137,45)	0.05 milligrams per deciliter (mg/dL) Standard Deviation 0.24	0.08 milligrams per deciliter (mg/dL) Standard Deviation 0.20
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 Baseline (n=159,51)	1.72 milligrams per deciliter (mg/dL) Standard Deviation 0.51	1.77 milligrams per deciliter (mg/dL) Standard Deviation 0.51
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 4 (n=157,51)	0.06 milligrams per deciliter (mg/dL) Standard Deviation 0.21	0.11 milligrams per deciliter (mg/dL) Standard Deviation 0.30
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 8 (n=147,47)	0.06 milligrams per deciliter (mg/dL) Standard Deviation 0.21	0.09 milligrams per deciliter (mg/dL) Standard Deviation 0.24
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 16 (n=134,44)	0.09 milligrams per deciliter (mg/dL) Standard Deviation 0.30	0.09 milligrams per deciliter (mg/dL) Standard Deviation 0.29

SECONDARY outcome

Timeframe: Baseline, Week 12, and Week 16

Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Serum Cystatin C at Weeks 12 and 16 Baseline (n=159,51)	1.54 mg/dL Standard Deviation 0.43	1.52 mg/dL Standard Deviation 0.41
Change From Baseline in Serum Cystatin C at Weeks 12 and 16 Change From Baseline at Week 12 (n=136,45)	0.03 mg/dL Standard Deviation 0.25	0.03 mg/dL Standard Deviation 0.21
Change From Baseline in Serum Cystatin C at Weeks 12 and 16 Change From Baseline at Week 16 (n=134,44)	0.05 mg/dL Standard Deviation 0.26	0.06 mg/dL Standard Deviation 0.25

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12 and 16

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=159 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=51 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 Baseline (n=159,51)	7.51 percent Standard Deviation 1.22	7.91 percent Standard Deviation 1.42
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 4 (n=157,51)	0.03 percent Standard Deviation 0.46	-0.04 percent Standard Deviation 0.46
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 8 (n=147,46)	-0.02 percent Standard Deviation 0.64	-0.08 percent Standard Deviation 0.71
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 12 (n=137,44)	-0.01 percent Standard Deviation 0.76	-0.06 percent Standard Deviation 0.81
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 Change From Baseline at Week 16 (n=133,44)	0.04 percent Standard Deviation 0.89	-0.04 percent Standard Deviation 1.13

SECONDARY outcome

Timeframe: 1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12

Population: The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=30 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=140 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Day 1: 1 Hour Post-Dose (n=29,124)	434.5 ng/mL Geometric Coefficient of Variation 65	524.4 ng/mL Geometric Coefficient of Variation 83
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Day 1: 2 Hours Post-Dose (n=30,139)	579.3 ng/mL Geometric Coefficient of Variation 37	602.9 ng/mL Geometric Coefficient of Variation 52
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Day 1: 4 Hours Post-Dose (n=29,137)	497.4 ng/mL Geometric Coefficient of Variation 38	547.7 ng/mL Geometric Coefficient of Variation 46
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Week 1: Pre-Dose (n=28,131)	294.4 ng/mL Geometric Coefficient of Variation 60	231.2 ng/mL Geometric Coefficient of Variation 73
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Week 1: 2 Hours Post-Dose (n=28,132)	884.8 ng/mL Geometric Coefficient of Variation 42	865.0 ng/mL Geometric Coefficient of Variation 55
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Week 4: Pre-Dose (n=25,126)	231.3 ng/mL Geometric Coefficient of Variation 51	239.5 ng/mL Geometric Coefficient of Variation 87
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Week 4: 2 Hours Post-Dose (n=24,122)	785.8 ng/mL Geometric Coefficient of Variation 45	918 ng/mL Geometric Coefficient of Variation 55
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Week 8: Pre-Dose (n=23,113)	310.2 ng/mL Geometric Coefficient of Variation 79	245.2 ng/mL Geometric Coefficient of Variation 77
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Week 8: 2 Hours Post-Dose (n=23,114)	730.0 ng/mL Geometric Coefficient of Variation 70	895 ng/mL Geometric Coefficient of Variation 57
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 Week 12 (n=20,113)	320.1 ng/mL Geometric Coefficient of Variation 75	252.3 ng/mL Geometric Coefficient of Variation 84

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12 and 16

Population: The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=170 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=56 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine SBP: Baseline (n=168,53)	140.4 millimeters of mercury (mm Hg) Standard Deviation 13.96	139.9 millimeters of mercury (mm Hg) Standard Deviation 13.60
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine SBP:Change From Baseline Week 1 (n=164,53)	-0.8 millimeters of mercury (mm Hg) Standard Deviation 12.75	-1.6 millimeters of mercury (mm Hg) Standard Deviation 12.87
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine SBP:Change From Baseline Week 4 (n=154,49)	-0.5 millimeters of mercury (mm Hg) Standard Deviation 15.43	-1.6 millimeters of mercury (mm Hg) Standard Deviation 14.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine SBP:Change From Baseline Week 8 (n=142,47)	-3.4 millimeters of mercury (mm Hg) Standard Deviation 12.94	-1.1 millimeters of mercury (mm Hg) Standard Deviation 13.71
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine SBP:Change From Baseline Week 12 (n=134,45)	-2.0 millimeters of mercury (mm Hg) Standard Deviation 13.28	-1.3 millimeters of mercury (mm Hg) Standard Deviation 13.23
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine SBP:Change From Baseline Week 16 (n=138,45)	-2.4 millimeters of mercury (mm Hg) Standard Deviation 15.14	-0.3 millimeters of mercury (mm Hg) Standard Deviation 14.41
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine DBP: Baseline (n=168,53)	75.9 millimeters of mercury (mm Hg) Standard Deviation 8.97	77.1 millimeters of mercury (mm Hg) Standard Deviation 6.88
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine DBP:Change From Baseline Week 1 (n=164,53)	-0.2 millimeters of mercury (mm Hg) Standard Deviation 6.94	-2.7 millimeters of mercury (mm Hg) Standard Deviation 7.58
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine DBP:Change From Baseline Week 4 (n=154,49)	0.1 millimeters of mercury (mm Hg) Standard Deviation 8.23	-1.8 millimeters of mercury (mm Hg) Standard Deviation 7.47
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine DBP:Change From Baseline Week 8 (n=142,47)	-1.9 millimeters of mercury (mm Hg) Standard Deviation 7.46	-1.5 millimeters of mercury (mm Hg) Standard Deviation 7.05
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine DBP:Change From Baseline Week 12 (n=134,45)	-0.9 millimeters of mercury (mm Hg) Standard Deviation 6.88	-0.2 millimeters of mercury (mm Hg) Standard Deviation 6.69
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16 Supine DBP:Change From Baseline Week 16 (n=138,45)	-1.7 millimeters of mercury (mm Hg) Standard Deviation 7.98	0.9 millimeters of mercury (mm Hg) Standard Deviation 8.40

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12 and 16

Population: The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=170 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=56 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16 Baseline (n=168,53)	68.7 beats per minute (bpm) Standard Deviation 9.74	69.3 beats per minute (bpm) Standard Deviation 9.30
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 1 (n=164,53)	0.1 beats per minute (bpm) Standard Deviation 5.86	-0.7 beats per minute (bpm) Standard Deviation 5.63
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 4 (n=154,49)	0.3 beats per minute (bpm) Standard Deviation 6.01	-1.0 beats per minute (bpm) Standard Deviation 6.63
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 8 (n=142,47)	0.2 beats per minute (bpm) Standard Deviation 6.54	1.4 beats per minute (bpm) Standard Deviation 6.77
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 12 (n=134,45)	0.2 beats per minute (bpm) Standard Deviation 7.03	0.5 beats per minute (bpm) Standard Deviation 7.33
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 16 (n=138,45)	1.4 beats per minute (bpm) Standard Deviation 8.22	-0.1 beats per minute (bpm) Standard Deviation 6.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 1, 4, 8, 12 and 16

Population: The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=170 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=56 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16 Baseline (n=167,53)	93.8 kilograms (kg) Standard Deviation 23.97	95.1 kilograms (kg) Standard Deviation 25.95
Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 16 (n=137,45)	-0.1 kilograms (kg) Standard Deviation 2.79	0.2 kilograms (kg) Standard Deviation 3.37
Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 1 (n=163,53)	0.0 kilograms (kg) Standard Deviation 1.03	0.3 kilograms (kg) Standard Deviation 1.42
Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 4 (n=153,49)	-0.0 kilograms (kg) Standard Deviation 1.74	0.4 kilograms (kg) Standard Deviation 3.29
Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 8 (n=141,47)	0.1 kilograms (kg) Standard Deviation 2.45	0.7 kilograms (kg) Standard Deviation 2.74
Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16 Change From Baseline at Week 12 (n=134,45)	0.3 kilograms (kg) Standard Deviation 2.66	0.7 kilograms (kg) Standard Deviation 3.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 16 (follow-up visit)

Population: The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.

The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen \[BUN\], creatinine, albumin, calcium, bilirubin \[total, direct, and indirect\], gamma-glutamyl transferase \[GGT\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], lactic dehydrogenase \[LDH\], alkaline phosphatase, creatine phosphokinase \[CPK\], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, white blood cell \[WBC\] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=167 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=53 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern	154 participants	49 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 1, 4 and 12

Population: The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.

Criteria for potentially clinically important ECG values were defined as: PR interval \>=300 milliseconds (msec) or \>=25%/50% increase when baseline is \>200 msec and ≥50% increase when baseline is less than or equal to (\<=)200 msec; QRS interval \>=140 msec or \>=50% increase from baseline (IFB); QTc \>=450 msec or \>=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) \>=450 msec or \>=30 msec increase.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=170 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=56 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings QRS Complex >=50% IFB (n=169,55)	3 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings QTc Interval >=60 msec IFB (n=169,55)	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings QTcF Interval 30-<60 msec IFB (n=169,55)	8 participants	3 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings QTcF Interval >=60 msec IFB (n=169,55)	1 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum PR Interval >=300 msec (n=164,55)	3 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QRS Complex >=140 msec (n=169,56)	2 participants	1 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QT Interval >=500 msec (n=169,56)	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QTc Interval 450-<480 msec (n=169,56)	23 participants	11 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QTc Interval 480-<500 msec (n=169,56)	4 participants	1 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QTc Interval >=500 msec (n=169,56)	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QTcF Interval 450-<480 msec (n=169,56)	11 participants	5 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QTcF Interval 480-<500 msec (n=169,56)	1 participants	1 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings Maximum QTcF Interval >=500 msec (n=169,56)	1 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings PR Interval >=25/50% IFB (n=163,53)	3 participants	0 participants
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings QTc Interval 30-<60 msec IFB (n=169,55)	15 participants	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last study drug administration

Population: The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.

An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A 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-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=170 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=56 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) AEs	106 participants	36 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) SAEs	17 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to Week 16 (follow-up visit)

Outcome measures

Outcome measures
Measure	PF-04634817 200 mg/150 mg n=167 Participants Participants were dosed orally at 150 mg (eGFR 20-\<30 mL/min/1.73 m\^2) or 200 mg (30-75 mL/min/1.73 m\^2) QD for 12 weeks.	Placebo n=53 Participants Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Number of Participants With Increased Fasting Blood Glucose	1 participants	0 participants

Adverse Events

PF-04634817 150 mg

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

PF-04634817 200 mg

Serious events: 11 serious events

Other events: 40 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PF-04634817 150 mg n=30 participants at risk Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (\<)30 milliliters/minute (mL/min)/1.73 square meter (m\^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.	PF-04634817 200 mg n=140 participants at risk Participants with eGFR values of 30 to 75 mL/min/1.73 m\^2 were dosed orally at 200 mg QD for 12 weeks.	Placebo n=56 participants at risk Participants were dosed orally with matching placebo tablets QD for 12 weeks.
Gastrointestinal disorders Diarrhoea	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	8.6% 12/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.4% 3/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.6% 5/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.6% 2/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Oedema peripheral	10.0% 3/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.7% 8/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	7.1% 4/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Nasopharyngitis	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.3% 6/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.4% 3/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Infections and infestations Upper respiratory tract infection	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.6% 5/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	3.6% 2/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Investigations Gamma-glutamyltransferase increased	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.71% 1/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.71% 1/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.8% 1/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 2/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.8% 1/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.4% 2/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.8% 1/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Nervous system disorders Dizziness	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	2.9% 4/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.8% 1/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Renal and urinary disorders Dysuria	6.7% 2/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	1.8% 1/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Vascular disorders Hypertension	3.3% 1/30 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.3% 6/140 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	5.4% 3/56 • Baseline up to 28 days after last study drug administration The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER