Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01003691
• Collaborator: (none)
• Enrollment: 24
• Locations: 24
• Arm: 1
• Actual Duration (Months): 32.5
• Patient Per Site: 1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Maculopathy; Age-Related Maculopathies; Eye Diseases; Retinal Degeneration; Macular Degeneration	Biological: RN6G; Biological: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 1, DOUBLE-MASKED, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY, TOLERABILITY, IMMUNOGENICITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF MULTIPLE ESCALATING DOSAGES OF RN6G (PF-04382923) IN SUBJECTS WITH ADVANCED DRY, AGE-RELATED MACULAR DEGENERATION (AMD) INCLUDING GEOGRAPHIC ATROPHY
• Actual Study Start Date: Aug 5, 2010
• Actual Primary Completion Date: Mar 5, 2013
• Actual Study Completion Date: Apr 19, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Biological: RN6G; Intravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg; Biological: Placebo; Intravenous, multiple dose with experimental dose

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Toxicity or Intolerable Dose Criteria [Baseline up to Day 304/End of Treatment (ET)]

   The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade >= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade >= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval [Fridericia's correction]), Grade >=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia <100*10 9 /liter.

2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity [Baseline up to Day 304/ET]

   AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. AE was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).

3. Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug [Baseline up to Day 304/ET]

   All causalities AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship. Drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. All causalities and drug-related AEs reported wherein drug-related AEs were reported as ocular and non-ocular AEs. Ocular AEs were events which were localized in the ocular region and non-ocular AEs were systemic events which were not localized but occurred throughout the systemic circulation.

4. Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity [Baseline up to Day 304/ET]

   AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AE were events which were localized in the ocular region and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).

5. Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug [Baseline up to Day 304/ET]

   AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were events which were localized in the ocular region. Ocular AEs reported as related and non-related to study drug.

6. Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity [Baseline up to Day 304/ET]

   AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic AE were events which were not localized but occurred throughout the systemic circulation and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).

7. Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug [Baseline up to Day 304/ET]

   AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic TEAEs were events which were not localized but occurred throughout the systemic circulation and reported as related and non-related to study drug.

8. Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) [Baseline up to Day 304/ET]

   The immunogenicity of RN6G (PF-04382923) in terms of producing an antidrug antibody (ADA) and neutralizing antibody response were assessed. Neutralizing antibody response were to be assess in participants with positive ADA samples.

Secondary Outcome Measures

1. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672 hours on Day 140]

   Area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau = 672 hours.

2. Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

3. Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

4. Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

   Css is the concentration of the drug at the state when the amount of drug administered is equal to the amount of drug eliminated.

5. Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

6. Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

   Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

7. Mean Residence Time (MRT) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

   The mean total time drug resides in the body.

8. Systemic Clearance (CL) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

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

9. Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) [Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

10. Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET [Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET]

    Amyloid (A) Beta (1-X) is a primary activator of complement in Alzheimer's disease (AD).

11. Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET [Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET]

12. Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET [Baseline, Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET]

13. Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET [Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET]

14. Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET [Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET]

15. Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET [Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET]

16. Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure [Baseline, 1 and 4 hour (H) post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET]

17. Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate [Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET]

18. Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature [Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET]

19. Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight [Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET]

20. Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET]

    Criteria for changes in ECG (12-lead) were defined as: PR interval >=220 millisecond (msec) and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Bazett's formula (QTcB) >=500 msec; Maximum Change from Baseline in QTcF at Borderline >=30 msec to <60 msec and Prolonged >=60 msec.

21. Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET]

22. Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

    Following parameters were analyzed for laboratory examination: Bilirubin, Direct Bilirubin, Blood Urea Nitrogen(BUN), Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol (CL)(Fasting), Triglycerides (Fasting) (TG), Immunoglobulin G (Ig G), Immunoglobulin A (Ig A), Immunoglobulin M (Ig M)

23. Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

24. Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

    Following parameters were analyzed for laboratory examination: Aspartate Aminotransferase (AMT), Creatine Kinase (CK), Alanine Aminotransferase (ALT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD), Alkaline Phosphatase (AP).

25. Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

26. Change From Baseline in Laboratory Assessments: Hematocrit at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

    Following hematology parameters were analyzed for laboratory examination: Hemoglobin, Hematocrit, Red blood cell (RBC) count, Platelet count, WBC count, Total neutrophils (Abs),Eosinophils (Abs),Monocytes (Abs),Basophils (Abs), Lymphocytes (Abs).

27. Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

28. Change From Baseline in Laboratory Assessments: Platelets, White Blood Cells (WBCs), Neutrophils (Absolute), Eosinophils (Absolute), Basophils (Absolute), Lymphocytes (Absolute), Monocytes (Absolute) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

29. Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

    Following hematology parameters were analyzed for laboratory examination: Prothrombin Time (PT), Partial Thromboplastin Time.

30. Change From Baseline in Laboratory Assessments: Urine Specific Gravity at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

    Urine specific gravity is a measure of the ratio of the density of urine to the density of water.

31. Change From Baseline in Laboratory Assessments: Urine pH at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

    Urine pH is a method for evaluating urine acidity measured on a 10-point scale ranging from 0 (most acidic) to 9 (most alkaline). A lower pH means more acidity.

32. Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 [Baseline, Day 28, 56, 84, 112, 140]

33. Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 [Baseline, Day 28, 56, 84, 112, 140]

34. Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 [Baseline, Day 28, 56, 84, 112, 140]

35. Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET]

36. Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET [Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET]

    QT interval corrected using the Fridericia formula (QTcF) >=500 msec; Maximum Change from Baseline in QTcF at Borderline >=30 msec to <60 msec and Prolonged >=60 msec.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be of non-child bearing potential

• Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement

• BCVA of 20/50 or better in the study eye

Exclusion Criteria:

• Evidence of ocular disease other than advanced AMD or GA in the study eye

• History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study eye

• Presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous immune, or gastrointestinal system

• Requires ocular or systemic medications that are known to be toxic to the lens, retina or optic nerve

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Diagnostic Center	Campbell	California	United States	95008
2	American Institute of Research (Administrative Only)	Los Gatos	California	United States	95032
3	Neurology Center Rai Kumar	San Jose	California	United States	95116
4	Harmeet Sachdev, MD, FAAN	San Jose	California	United States	95124
5	Santa Clara Drug	San Jose	California	United States	95128
6	Retina Associates of Florida, PA	Tampa	Florida	United States	33609
7	Hoye's Pharmacy	Tampa	Florida	United States	33611
8	Ranjit K. Sethi, MD, PC	Augusta	Georgia	United States	30901
9	Clinical Specialists, LLC	Augusta	Georgia	United States	30907
10	Southeast Retina Center, PC	Augusta	Georgia	United States	30909
11	University of Rochester Medical Center	Rochester	New York	United States	14642
12	University of Rochester	Rochester	New York	United States	14642
13	Hawthorne Pharmacy	West Columbia	South Carolina	United States	29169
14	Jay Markowitz and Associates	West Columbia	South Carolina	United States	29169
15	Palmetto Retina Center, LLC	West Columbia	South Carolina	United States	29169
16	South Carolina Neurological	West Columbia	South Carolina	United States	29169
17	National Central Pharmacy	Abilene	Texas	United States	79605
18	Abilene Surgery Center	Abilene	Texas	United States	79606
19	Heart and Vascular Institute	Abilene	Texas	United States	79606
20	Retina Research Institute of Texas	Abilene	Texas	United States	79606
21	Brian B. Berger, MD, PA	Austin	Texas	United States	78705
22	Retina Research Center, PLLC	Austin	Texas	United States	78705
23	Sleep Medicine Consultants	Austin	Texas	United States	78731
24	Specialty Compounding	Cedar Park	Texas	United States	78613

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

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: NCT01003691
• Other Study ID Numbers: B1181002
• First Posted: Oct 29, 2009
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Phase 1b Advanced Dry Age-Related Macular Degeneration RN6G
• Additional relevant MeSH terms: Macular Degeneration; Eye Diseases; Geographic Atrophy; Retinal Degeneration; Atrophy

Study Results

Participant Flow

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Period Title: Overall Study
STARTED	6	6	6	6
COMPLETED	6	6	6	5
NOT COMPLETED	0	0	0	1

Baseline Characteristics

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo	Total
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.	Total of all reporting groups
Overall Participants	6	6	6	6	24
Age, Customized (Count of Participants)
60 to less than (<) 75 years	3 50%	3 50%	3 50%	2 33.3%	11 45.8%
Greater than or equal to (>=) 75 years	3 50%	3 50%	3 50%	4 66.7%	13 54.2%
Sex: Female, Male (Count of Participants)
Female	4 66.7%	1 16.7%	5 83.3%	3 50%	13 54.2%
Male	2 33.3%	5 83.3%	1 16.7%	3 50%	11 45.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	1 16.7%	1 4.2%
Not Hispanic or Latino	6 100%	6 100%	6 100%	5 83.3%	23 95.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	6 100%	6 100%	6 100%	5 83.3%	23 95.8%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	1 16.7%	1 4.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Toxicity or Intolerable Dose Criteria
Description	The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade >= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade >= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval [Fridericia's correction]), Grade >=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia <100*10 9 /liter.
Time Frame	Baseline up to Day 304/End of Treatment (ET)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Number [Participants]	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Description	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. AE was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Time Frame	Baseline up to Day 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Grade 1	1 16.7%	3 50%	0 0%	0 0%
Grade 2	5 83.3%	3 50%	4 66.7%	5 83.3%
Grade 3	0 0%	0 0%	2 33.3%	1 16.7%
Grade 4	0 0%	0 0%	0 0%	0 0%
Grade 5	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug
Description	All causalities AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship. Drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. All causalities and drug-related AEs reported wherein drug-related AEs were reported as ocular and non-ocular AEs. Ocular AEs were events which were localized in the ocular region and non-ocular AEs were systemic events which were not localized but occurred throughout the systemic circulation.
Time Frame	Baseline up to Day 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
All causalities AE	6 100%	6 100%	6 100%	6 100%
Drug-related Ocular AE	0 0%	0 0%	0 0%	0 0%
Drug-related non-ocular AE	2 33.3%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Description	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AE were events which were localized in the ocular region and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Time Frame	Baseline up to Day 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Grade 1	4 66.7%	4 66.7%	0 0%	2 33.3%
Grade 2	0 0%	0 0%	3 50%	2 33.3%
Grade 3	0 0%	0 0%	0 0%	0 0%
Grade 4	0 0%	0 0%	0 0%	0 0%
Grade 5	0 0%	0 0%	0 0%	0 0%

5. Primary Outcome

Title	Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Description	AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were events which were localized in the ocular region. Ocular AEs reported as related and non-related to study drug.
Time Frame	Baseline up to Day 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Related	0 0%	0 0%	0 0%	0 0%
Not Related	4 66.7%	4 66.7%	3 50%	4 66.7%

6. Primary Outcome

Title	Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Description	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic AE were events which were not localized but occurred throughout the systemic circulation and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).
Time Frame	Baseline up to Day 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Grade 1	1 16.7%	3 50%	0 0%	0 0%
Grade 2	5 83.3%	3 50%	4 66.7%	5 83.3%
Grade 3	0 0%	0 0%	2 33.3%	1 16.7%
Grade 4	0 0%	0 0%	0 0%	0 0%
Grade 5	0 0%	0 0%	0 0%	0 0%

7. Primary Outcome

Title	Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Description	AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic TEAEs were events which were not localized but occurred throughout the systemic circulation and reported as related and non-related to study drug.
Time Frame	Baseline up to Day 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Related	2 33.3%	0 0%	0 0%	0 0%
Not related	4 66.7%	6 100%	6 100%	6 100%

8. Secondary Outcome

Title	Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923)
Description	Area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau = 672 hours.
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672 hours on Day 140

Outcome Measure Data

Analysis Population Description

Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluated for specified category.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Day 1	NA (NA)	NA (NA)
Day 140	50230 (20)	140300 (14)	213200 (16)

9. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923)
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Day 1	142.9 (12)	283.4 (18)	524.1 (66)
Day 140	185.1 (16)	439.8 (15)	691.7 (12)

10. Secondary Outcome

Title	Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923)
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter (mcg/mL)]	38.43 (40)	119.7 (23)	201.5 (27)

11. Secondary Outcome

Title	Plasma Concentration (Css) at Steady State of RN6G (PF-04382923)
Description	Css is the concentration of the drug at the state when the amount of drug administered is equal to the amount of drug eliminated.
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter (mcg/mL)]	74.75 (20)	208.7 (14)	317.2 (16)

12. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923)
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Day 1	1.49	2.06	2.17
Day 140	1.77	2.05	1.32

13. Secondary Outcome

Title	Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923)
Description	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Geometric Mean (Geometric Coefficient of Variation) [Milliliter per kilogram (mL/kg)]	79.52 (23)	88.04 (26)	78.45 (11)

14. Secondary Outcome

Title	Mean Residence Time (MRT) of RN6G (PF-04382923)
Description	The mean total time drug resides in the body.
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Mean (Standard Deviation) [Hour]	818.1 (182.15)	1274 (352.28)	1121 (135.38)

15. Secondary Outcome

Title	Systemic Clearance (CL) of RN6G (PF-04382923)
Description	CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Geometric Mean (Geometric Coefficient of Variation) [Milliliter per hour per kilogram]	0.09954 (20)	0.07129 (14)	0.07036 (16)

16. Secondary Outcome

Title	Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923)
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Overall Number of participants Analyzed" signifies number of participants evaluable for this outcome measure.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	5
Mean (Standard Deviation) [Hour]	25.14 (5.0774)	42.00 (6.6321)	38.10 (4.9738)

17. Secondary Outcome

Title	Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Description	Amyloid (A) Beta (1-X) is a primary activator of complement in Alzheimer's disease (AD).
Time Frame	Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo matching to PF-04382923 in dosages ranging from 5 to 15 mg/kg as intravenous infusion over 60 minutes followed by a 5 mL flush of 0.9% Sodium Chloride Injection, every 4 weeks, for a total of up to 6 doses.
Measure Participants	6	6	6	6
Baseline	371.8 (284.73)	1596.8 (2794.08)	200.0 (0.00)	386.5 (174.33)
Change at 1H post-dose Day 1	3340.5 (386.71)	3205.5 (856.06)	3947.2 (1822.39)	0.3 (83.39)
Change at 2H post-dose Day 1	5118.7 (709.00)	4821.2 (1114.32)	5610.8 (2544.70)	45.3 (125.22)
Change at 4H post-dose Day 1	7850.0 (1490.33)	6992.7 (1716.83)	7874.3 (2158.56)	1.7 (225.19)
Change at Day 2	33804.2 (5420.83)	33566.0 (4698.42)	37862.0 (1069.86)	-9.8 (132.42)
Change at Day 7	50329.3 (9389.75)	88678.7 (22431.39)	94017.0 (7060.55)	16.8 (52.82)
Change at Day 14	25303.0 (4293.92)	69611.3 (21077.31)	80138.0 (13795.55)	-66.2 (103.72)
Change at Day 19	17782.7 (4264.51)	54407.7 (15467.03)	71190.6 (7553.42)	-62.5 (106.16)
Change at Day 28	8777.5 (1441.65)	35848.3 (9540.26)	57701.0 (14705.10)	-69.7 (239.14)
Change at Day 45	41329.3 (12376.68)	87735.4 (19304.46)	110278.0 (20296.92)	-6.5 (209.72)
Change at Day 56	23723.0 (4080.35)	70846.5 (24378.68)	98343.8 (21336.44)	-36.3 (305.27)
Change at Day 75	42393.7 (7739.27)	121176.2 (34652.27)	149272.0 (23898.10)	205.6 (302.40)
Change at Day 84	29386.3 (3246.30)	89908.2 (28896.82)	120091.6 (5895.10)	122.2 (362.01)
Change at Day 103	50269.8 (7129.73)	114474.3 (28268.90)	157448.0 (33235.41)	116.6 (296.52)
Change at Day 112	34071.5 (4062.24)	107243.5 (28813.61)	140917.6 (17498.78)	214.4 (342.45)
Change at Day 131	62226.8 (17554.96)	124417.0 (26689.05)	168767.8 (7272.93)	-61.6 (131.01)
Change at pre-dose Day 140	46295.7 (7585.69)	102548.2 (22902.22)	154350.0 (9459.75)	-3.4 (92.42)
Change at 1 H post-dose Day 140	41991.0 (7209.04)	98349.2 (20226.44)	140246.0 (15770.21)	-25.0 (80.53)
Change at 2 H Post-dose Day 140	49017.8 (6793.71)	102384.7 (17624.73)	136109.5 (12883.65)	-137.3 (135.93)
Change at 4 H Post-dose Day 140	51102.8 (6552.83)	101938.3 (21440.86)	153793.0 (15312.09)	-144.2 (158.04)
Change at Day 141	27212.1 (12018.62)	36042.0 (25934.30)	80464.2 (11546.49)	-11.0 (30.66)
Change at Day 154	141033.8 (22685.63)	190913.6 (29331.01)	-103.5 (85.83)
Change at Day 168	52558.0 (6374.13)	103651.8 (27880.97)	161691.4 (21292.74)	-64.6 (132.40)
Change at Day 224	20950.3 (6951.30)	35489.0 (11571.26)	57692.0 (16310.16)	-110.3 (138.97)
Change at day 304/ET	13550.8 (5901.76)	12127.2 (3196.16)	-164.3 (167.57)

18. Secondary Outcome

Title	Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time Frame	Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Percent change at 1 H post-dose Day 1	1194.4 (541.02)	1032.9 (860.01)	1973.6 (911.19)	3.8 (21.25)
Percent change at 2 H post-dose Day 1	1835.9 (859.97)	1682.9 (1332.55)	2805.4 (1272.35)	17.7 (37.96)
Percentage change at 4 H post-dose Day 1	2899.5 (1575.11)	2044.5 (1595.93)	3937.1 (1079.28)	14.5 (61.22)
Percent change at Day 2	11999.3 (5344.01)	9771.3 (6115.66)	18931.0 (534.93)	4.3 (29.32)
Percent change at Day 7	17643.7 (7989.43)	22214.1 (16132.62)	47008.5 (3530.28)	3.1 (13.89)
Percent change at Day 14	8930.3 (3978.36)	16692.0 (11490.17)	40069.0 (6897.78)	-12.4 (20.10)
Percent change at Day 19	6096.9 (2660.58)	13136.7 (9098.67)	35595.3 (3776.71)	-13.2 (18.08)
Percent change at Day 28	3168.7 (1297.49)	8714.5 (5831.88)	28850.5 (7352.55)	-3.3 (72.57)
Percent change at Day 45	14458.4 (7747.84)	25626.3 (16350.32)	55139.0 (10148.46)	19.0 (84.63)
Percent change at Day 56	8156.5 (3005.78)	16396.4 (11269.80)	49171.9 (10668.22)	20.9 (120.63)
Percent change at Day 75	14815.6 (6477.51)	29483.6 (20874.07)	74636.0 (11949.05)	72.3 (122.02)
Percent change at Day 84	10497.3 (4494.06)	21128.7 (14305.48)	60045.8 (2947.55)	51.2 (124.25)
Percent change at Day 103	17482.8 (6740.53)	28726.4 (20620.23)	78724.0 (16617.70)	48.2 (120.26)
Percent change at Day 112	12401.6 (5938.63)	26653.1 (19128.49)	70458.8 (8749.39)	75.8 (138.85)
Percent change at Day 131	20902.9 (8509.92)	31839.9 (22850.11)	84383.9 (3636.46)	-6.5 (28.29)
Percent change at Pre-dose Day 140	16323.4 (6890.74)	26584.4 (19667.93)	77175.0 (4729.87)	6.8 (25.29)
Percent change at 1 H Post dose Day 140	15067.2 (6922.60)	25462.2 (18562.61)	70123.0 (7885.10)	-2.3 (23.04)
Percent change at 2 H Post dose Day 140	17418.4 (7204.24)	27192.5 (19768.55)	68054.8 (6441.82)	-25.9 (21.26)
Percent change at 4 H Post dose Day 140	18171.1 (7481.91)	26342.6 (19070.40)	76896.5 (7656.04)	-29.4 (24.61)
Percent change at Day 141	27212.1 (12018.62)	36042.0 (25934.30)	80464.2 (11546.49)	-11.0 (30.66)
Percent change at Day 154	37731.7 (28276.18)	95456.8 (14665.51)	-21.2 (14.56)
Percent change at Day 168	19415.4 (9203.47)	26639.1 (19545.03)	80845.7 (10646.37)	-10.1 (29.15)
Percent change at Day 224	7954.0 (5003.96)	9003.9 (7319.06)	28846.0 (8155.08)	-22.2 (27.76)
Percent change at Day 304 / ET	3182.9 (2499.39)	6063.6 (1598.08)	-31.6 (27.03)

19. Secondary Outcome

Title	Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time Frame	Baseline, Day 1 (1 hour , 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline	160.4 (36.33)	199.7 (24.19)	209.2 (13.26)	224.3 (61.26)
Change at 1H post-dose Day 1	1271.3 (131.35)	1306.4 (184.77)	1548.8 (398.99)	-3.7 (21.10)
Change at 2 H post-dose Day 1	1939.6 (185.16)	2082.4 (457.09)	2264.8 (438.40)	-0.7 (27.10)
Change at 4 H post-dose Day 1	3159.6 (510.52)	3290.3 (525.32)	3202.3 (730.89)	4.2 (27.80)
Change at Day 2	10071.3 (1097.81)	10256.8 (1125.20)	11164.8 (563.89)	-5.5 (21.94)
Change at Day 7	12089.6 (2224.22)	18817.0 (4600.38)	24150.8 (3178.81)	-2.8 (16.02)
Change at Day 14	6047.9 (751.77)	16450.3 (4571.75)	19050.8 (3495.78)	-6.5 (13.91)
Change at Day 19	4626.3 (506.10)	12467.0 (3360.84)	17990.8 (4568.62)	8.2 (27.46)
Change at Day 28	2809.6 (534.82)	9117.0 (2492.73)	15410.8 (3844.36)	-3.0 (17.44)
Change at Day 45	10302.9 (2886.26)	18746.0 (4221.27)	24150.8 (1138.42)	-7.7 (46.88)
Change at Day 56	6352.9 (513.41)	14645.3 (5174.94)	20630.8 (3400.87)	-16.8 (46.67)
Change at Day 75	10751.3 (796.75)	24750.3 (5951.71)	26910.8 (1110.60)	-33.0 (24.37)
Change at Day 84	7687.9 (915.03)	20800.3 (6538.53)	23270.8 (1691.32)	-15.6 (61.32)
Change at Day 103	12239.6 (1315.07)	25900.3 (6385.93)	29170.8 (5936.75)	-15.6 (36.92)
Change at Day 112	8517.9 (1608.78)	23517.0 (6359.32)	28250.8 (2534.65)	-18.6 (35.53)
Change at Day 131	15272.9 (2939.43)	26550.3 (5860.63)	37614.8 (8703.34)	7.0 (56.04)
Change at pre-dose Day 140	10402.9 (1699.34)	20192.0 (10768.73)	33910.8 (4820.26)	26.8 (102.19)
Change at 1 H post-dose Day 140	12626.3 (2294.39)	25550.3 (6073.42)	34470.8 (7089.10)	-9.0 (41.35)
Change at 2 H Post-dose Day 140	13922.9 (2470.45)	26717.0 (5581.26)	36114.8 (6268.68)	-31.0 (27.60)
Change at 4 H Post-dose Day 140	15889.6 (1923.62)	25283.7 (5234.95)	36750.8 (14910.47)	-27.4 (38.63)
Change at Day 141	20889.6 (2456.19)	31733.7 (6395.71)	39990.8 (8261.80)	-24.2 (40.38)
Change at Day 154	25050.3 (5480.90)	47310.8 (2244.59)	-35.8 (37.98)
Change at Day 168	11557.9 (2152.82)	21517.0 (5926.14)	36750.8 (5023.07)	-20.4 (52.83)
Change at Day 224	3534.6 (1383.04)	8518.7 (2946.68)	14190.8 (3337.13)	15.3 (66.79)
Change at day 304/ET	2483.7 (1124.28)	3340.8 (994.48)	26.8 (87.01)

20. Secondary Outcome

Title	Percent Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time Frame	Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo matching to PF-04382923 in dosages ranging from 5 to 15 mg/kg as intravenous infusion over 60 minutes followed by a 5 mL flush of 0.9% Sodium Chloride Injection, every 4 weeks, for a total of up to 6 doses.
Measure Participants	6	6	6	6
Percent change at 1 H post-dose Day 1	838.8 (262.62)	660.9 (101.20)	752.8 (247.20)	0.4 (9.79)
Percent change at 2 H post-dose Day 1	1283.4 (428.98)	1051.5 (230.65)	1082.6 (225.11)	1.8 (12.92)
Percent change at 4 H post-dose Day 1	2129.1 (971.74)	1649.8 (190.06)	1509.3 (255.86)	3.2 (12.13)
Percent change at Day 2	6536.9 (1533.60)	5332.4 (437.02)	5328.4 (422.35)	-0.4 (10.07)
Percent change at Day 7	8153.4 (3691.20)	9483.1 (2136.77)	11658.5 (2346.26)	-1.0 (7.54)
Percent change at Day 14	4001.5 (1313.42)	8124.3 (1400.09)	9132.2 (1770.33)	-2.1 (5.38)
Percent change at Day 19	3048.1 (934.03)	6169.0 (996.40)	8606.3 (2099.47)	6.5 (15.76)
Percent change at Day 28	1836.7 (528.74)	4501.8 (758.64)	7485.9 (2422.75)	-0.7 (8.35)
Percent change at Day 45	6632.8 (2095.25)	9614.6 (1371.10)	11600.4 (1173.09)	1.0 (22.07)
Percent change at Day 56	4104.0 (781.38)	7229.3 (1982.40)	9938.9 (2032.57)	-2.8 (23.72)
Percent change at Day 75	7033.1 (1783.12)	12296.0 (1777.75)	12933.0 (1384.70)	-12.5 (9.43)
Percent change at Day 84	5034.2 (1396.44)	10287.0 (2294.92)	11153.8 (978.44)	-3.5 (28.74)
Percent change at Day 103	8033.3 (2202.15)	12858.0 (1914.67)	14043.1 (3217.61)	-4.5 (16.16)
Percent change at Day 112	5736.6 (2367.32)	11719.8 (2354.18)	13528.7 (1209.21)	-6.4 (15.20)
Percent change at Day 131	9742.8 (1628.75)	13197.8 (1567.68)	17840.0 (3578.16)	4.9 (23.25)
Percent change at Pre-dose Day 140	6750.1 (1605.57)	9991.6 (4745.47)	16216.1 (2105.17)	16.6 (51.02)
Percent change at 1 H Post dose Day 140	8274.4 (2373.14)	12713.5 (2035.10)	16473.9 (3063.74)	-1.5 (18.15)
Percent change at 2 H Post dose Day 140	9035.4 (2212.53)	13326.7 (1838.41)	17173.8 (2625.79)	-11.2 (9.09)
Percent change at 4 H Post dose Day 140	10332.3 (2454.30)	12606.4 (1626.29)	17656.9 (7083.30)	-9.6 (13.47)
Percent change at Day 141	13778.6 (4413.73)	15838.7 (2208.15)	19190.4 (4117.80)	-7.8 (15.61)
Percent change at Day 154	12461.9 (1481.16)	22722.9 (2317.53)	-12.7 (13.89)
Percent change at Day 168	7539.0 (2097.66)	10766.1 (2561.52)	17703.0 (3291.42)	-5.3 (22.33)
Percent change at Day 224	2277.4 (870.42)	4228.9 (1141.96)	6880.8 (2087.34)	14.5 (35.70)
Percent change at Day 304 / ET	1263.2 (640.49)	1603.7 (481.43)	10.9 (32.02)

21. Secondary Outcome

Title	Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time Frame	Baseline, Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline	34.0 (5.61)	67.3 (36.14)	46.9 (8.62)	61.4 (31.71)
Change at 1H post-dose Day 1	65.3 (15.08)	72.4 (14.51)	154.9 (49.51)	-7.7 (16.71)
Change at 2 H post-dose Day 1	84.6 (21.50)	126.8 (36.79)	193.9 (65.55)	-4.0 (19.86)
Change at 4 H post-dose Day 1	100.0 (18.50)	179.5 (34.06)	262.6 (113.24)	4.0 (5.75)
Change at Day 2	88.6 (32.58)	194.8 (48.89)	328.4 (99.74)	-13.3 (26.69)
Change at Day 7	42.1 (16.79)	77.4 (26.92)	144.1 (35.08)	3.9 (32.00)
Change at Day 14	18.7 (9.18)	42.4 (43.12)	75.9 (19.03)	9.1 (22.03)
Change at Day 19	13.9 (5.23)	33.2 (34.62)	71.2 (13.06)	8.4 (22.71)
Change at Day 28	4.8 (3.31)	8.4 (28.46)	68.3 (29.29)	-4.3 (11.73)
Change at Day 45	31.3 (7.24)	50.9 (31.77)	123.1 (23.36)	-12.6 (25.16)
Change at Day 56	18.0 (7.94)	56.6 (61.02)	101.3 (25.80)	-15.9 (28.84)
Change at Day 75	28.9 (11.25)	78.0 (51.53)	144.5 (29.38)	-22.3 (27.87)
Change at Day 84	25.6 (3.60)	56.3 (54.71)	104.1 (21.92)	-14.7 (26.98)
Change at Day 103	41.9 (6.37)	94.4 (49.79)	141.1 (47.02)	-17.8 (28.09)
Change at Day 112	26.2 (8.53)	88.2 (58.68)	124.9 (39.52)	-18.8 (22.91)
Change at Day 131	56.3 (11.71)	115.0 (68.50)	180.1 (18.23)	-19.9 (24.25)
Change at pre-dose Day 140	37.2 (8.51)	80.2 (59.94)	136.3 (9.43)	-10.9 (43.12)
Change at 1 H post-dose Day 140	87.8 (10.70)	177.5 (67.55)	257.7 (63.99)	-21.7 (25.89)
Change at 2 H Post-dose Day 140	113.2 (19.82)	209.2 (51.64)	292.9 (57.03)	-28.7 (31.64)
Change at 4 H Post-dose Day 140	132.3 (12.73)	243.7 (58.08)	360.9 (66.62)	-10.5 (39.49)
Change at Day 141	120.0 (15.08)	280.2 (81.80)	404.7 (84.86)	-26.1 (24.22)
Change at Day 154	113.4 (72.67)	229.5 (29.57)	-29.3 (25.98)
Change at Day 168	39.5 (4.78)	72.7 (50.70)	168.9 (34.85)	-21.9 (27.63)
Change at Day 224	8.6 (9.82)	-1.8 (41.26)	45.6 (14.60)	-8.5 (42.38)
Change at day 304/ET	-3.6 (40.36)	4.8 (5.31)	-35.9 (26.66)

22. Secondary Outcome

Title	Percent Change From Baseline in Plasma Amyloid (A) Beta (1-42) Concentrations at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET
Time Frame	Day 1 (1 hour, 2 hours, 4 hours post dose), 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140 (predose, 1 hour, 2 hours, 4 hours post dose), 141, 154, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo matching to PF-04382923 in dosages ranging from 5 to 15 mg/kg as intravenous infusion over 60 minutes followed by a 5 mL flush of 0.9% Sodium Chloride Injection, every 4 weeks, for a total of up to 6 doses.
Measure Participants	6	6	6	6
Percent change at 1 H post-dose Day 1	199.0 (74.28)	163.7 (102.35)	340.2 (133.10)	-7.0 (20.63)
Percent change at 2 H post-dose Day 1	257.8 (101.75)	254.3 (104.05)	412.7 (98.90)	0.5 (23.12)
Percent change at 4 H post-dose Day 1	306.4 (111.88)	341.8 (174.55)	545.8 (131.45)	10.4 (12.86)
Percent change at Day 2	278.1 (163.60)	461.6 (175.95)	708.5 (200.76)	-9.8 (31.29)
Percent change at Day 7	129.8 (71.07)	164.3 (114.69)	306.5 (45.29)	19.6 (58.46)
Percent change at Day 14	59.7 (38.36)	121.1 (132.70)	163.7 (37.92)	21.2 (47.33)
Percent change at Day 19	43.0 (20.81)	87.2 (92.62)	153.3 (25.60)	20.9 (49.01)
Percent change at Day 28	15.9 (14.37)	36.5 (57.79)	157.6 (103.15)	-2.6 (18.74)
Percent change at Day 45	92.5 (17.60)	118.9 (116.56)	267.5 (59.75)	-7.7 (30.53)
Percent change at Day 56	55.8 (34.06)	102.2 (74.51)	220.4 (62.44)	-10.7 (36.98)
Percent change at Day 75	87.8 (38.89)	172.1 (141.94)	314.3 (75.17)	-23.6 (27.01)
Percent change at Day 84	77.0 (16.80)	146.3 (146.97)	224.2 (40.97)	-12.4 (34.64)
Percent change at Day 103	128.9 (42.92)	207.3 (159.23)	315.3 (127.45)	-16.7 (29.36)
Percent change at Day 112	83.2 (46.16)	207.4 (176.39)	275.2 (92.55)	-20.2 (21.83)
Percent change at Day 131	168.4 (41.44)	249.0 (204.05)	393.6 (66.08)	-21.1 (25.48)
Percent change at Pre-dose Day 140	111.1 (25.89)	185.8 (164.10)	297.3 (48.94)	0.2 (68.99)
Percent change at 1 H Post dose Day 140	264.4 (55.03)	345.7 (201.63)	553.7 (122.06)	-24.0 (24.14)
Percent change at 2 H Post dose Day 140	337.7 (67.82)	394.6 (196.64)	637.8 (146.28)	-28.8 (33.79)
Percent change at 4 H Post dose Day 140	397.0 (70.71)	459.8 (234.24)	781.5 (165.36)	-4.9 (53.65)
Percent change at Day 141	360.6 (70.15)	539.2 (291.07)	889.4 (267.61)	-31.3 (20.95)
Percent change at Day 154	241.5 (196.56)	506.2 (142.03)	-32.3 (22.75)
Percent change at Day 168	119.7 (30.44)	176.4 (159.42)	366.6 (91.33)	-22.8 (27.34)
Percent change at Day 224	29.7 (37.85)	27.1 (74.59)	102.6 (41.52)	8.2 (68.87)
Percent change at Day 304 / ET	15.4 (66.96)	11.0 (12.78)	-38.8 (22.12)

23. Secondary Outcome

Title	Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Systolic and Diastolic Blood Pressure
Time Frame	Baseline, 1 and 4 hour (H) post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo matching to PF-04382923 in dosages ranging from 5 to 15 mg/kg as intravenous infusion over 60 minutes followed by a 5 mL flush of 0.9% Sodium Chloride Injection, every 4 weeks, for a total of up to 6 doses.
Measure Participants	6	6	6	6
Baseline: SBP	128.0 (10.58)	128.7 (18.05)	127.3 (7.37)	125.3 (12.19)
Change at 1H post-dose Day 1: SBP	11.3 (10.71)	-5.7 (16.56)	3.8 (11.70)	2.5 (6.38)
Change at 4 H post-dose Day 1: SBP	1.0 (8.56)	-1.3 (17.42)	2.2 (9.64)	2.7 (12.55)
Change at 24 H post-dose Day 2: SBP	5.0 (11.22)	-10.7 (18.53)	-5.0 (8.29)	0.8 (4.62)
Change at Day 7: SBP	7.3 (22.08)	-5.3 (15.47)	-1.5 (7.74)	-4.0 (4.15)
Change at Day 14: SBP	2.0 (15.13)	-1.5 (9.29)	-7.2 (11.84)	2.8 (7.49)
Change at Day 19: SBP	-1.3 (7.45)	-6.2 (9.43)	-8.6 (8.35)	-1.3 (3.20)
Change at pre-dose Day 28: SBP	7.7 (11.83)	-8.8 (10.09)	-1.3 (11.76)	-0.3 (9.56)
Change at 4-8 H post-dose Day 28: SBP	7.7 (10.61)	-5.5 (12.29)	3.6 (11.80)	7.3 (18.69)
Change at Day 45: SBP	3.7 (6.62)	0.3 (12.31)	-1.6 (23.42)	4.3 (7.12)
Change at pre-dose Day 56: SBP	5.0 (15.48)	-1.3 (9.61)	-4.5 (14.71)	3.2 (9.52)
Change at 4-8 H post-dose day 56: SBP	4.8 (10.82)	-1.7 (7.34)	-0.2 (11.58)	8.2 (17.48)
Change at Day 75: SBP	-0.7 (19.34)	-1.8 (16.57)	1.8 (15.88)	6.0 (11.77)
Change at Pre-dose Day 84: SBP	3.2 (15.05)	-0.8 (8.91)	-0.3 (15.88)	10.0 (9.67)
Change at 4-8H post-dose Day 84: SBP	0.0 (9.63)	-7.0 (12.62)	3.8 (10.30)	7.0 (13.58)
Change at Day 103: SBP	2.0 (13.08)	-1.3 (11.29)	5.5 (8.62)	11.4 (12.03)
Change at pre-dose Day 112: SBP	-2.0 (12.65)	-1.2 (17.28)	-0.5 (10.35)	12.8 (8.87)
Change at 4-8 H post-dose Day 112: SBP	-4.7 (8.26)	-2.7 (10.25)	-1.7 (11.64)	7.4 (14.62)
Change at Day 131: SBP	4.3 (13.11)	0.2 (12.59)	1.0 (9.75)	12.2 (13.20)
Change at pre-dose Day 140: SBP	-5.3 (15.78)	-2.3 (16.42)	-2.8 (8.16)	2.6 (8.56)
Change at 1 H post-dose Day 140: SBP	-0.7 (11.64)	-1.3 (12.75)	-1.0 (13.71)	5.4 (20.51)
Change at 4 H post dose Day 140: SBP	-6.0 (9.96)	-6.7 (16.44)	-3.3 (8.57)	12.4 (7.44)
Change at 24 H post dose Day 141: SBP	-6.0 (11.10)	-2.5 (10.43)	-0.7 (3.33)	10.2 (11.99)
Change at Day 154: SBP	-2.7 (8.80)	-6.7 (8.24)	0.3 (7.41)
Change at Day 168: SBP	5.8 (24.04)	-0.8 (11.18)	-11.8 (7.96)	5.2 (11.12)
Change at Day 224/ET: SBP	1.8 (15.83)	4.7 (14.88)	-3.0 (12.81)	5.5 (9.93)
Change at Day 304/ET: SBP	-1.7 (9.07)	0.5 (18.57)	2.3 (15.52)
Baseline: DBP	78.7 (7.55)	75.0 (10.56)	80.3 (7.74)	76.7 (5.99)
Change at 1 H post-dose Day 1: DBP	-0.3 (7.09)	3.5 (9.38)	3.0 (8.44)	-3.3 (7.26)
Change at 4 H post-dose Day 1: DBP	-3.7 (11.48)	-1.5 (8.09)	0.2 (8.01)	-4.3 (4.03)
Change at 24 H post-dose Day 2: DBP	-2.7 (8.36)	-0.7 (5.32)	-4.7 (8.80)	-2.2 (8.82)
Change at Day 7: DBP	-1.7 (11.48)	4.7 (8.26)	-2.7 (9.44)	-2.3 (6.47)
Change at Day 14: DBP	-1.3 (6.02)	3.7 (9.91)	-3.7 (10.63)	-1.3 (6.06)
Change at Day 19: DBP	-1.7 (7.84)	-1.2 (6.59)	-5.4 (4.45)	-3.7 (6.83)
Change at pre-dose Day 28: DBP	-1.0 (11.51)	-2.2 (8.95)	-2.8 (11.72)	-4.8 (8.16)
Change at 4-8 H post-dose Day 28:DBP	0.7 (6.53)	0.0 (12.90)	2.6 (4.22)	-4.5 (7.15)
Change at Day 45: DBP	1.7 (5.99)	5.8 (11.74)	-4.6 (11.99)	-2.0 (10.97)
Change at pre-dose Day 56: DBP	1.0 (5.33)	0.3 (10.98)	-1.0 (5.06)	2.3 (8.73)
Change at 4-8 H post-dose day 56: DBP	0.8 (5.00)	-0.5 (11.93)	1.4 (7.20)	-3.0 (6.44)
Change at Day 75: DBP	-0.3 (6.12)	-3.2 (10.01)	-4.6 (5.59)	-1.2 (6.53)
Change at pre-dose Day 84: DBP	-0.7 (8.45)	0.8 (14.76)	-1.2 (11.39)	2.2 (7.66)
Change at 4-8 H post-dose Day 84:DBP	-6.7 (7.97)	-3.0 (8.07)	0.5 (10.25)	-2.0 (6.67)
Change at Day 103: DBP	-5.0 (5.76)	0.3 (12.23)	2.2 (7.96)	3.4 (4.04)
Change at pre-dose Day 112: DBP	-1.8 (8.35)	3.3 (10.80)	-2.3 (5.01)	4.4 (4.39)
Change at 4-8 H post-dose Day 112:DBP	-1.3 (8.16)	0.0 (10.73)	-1.0 (6.93)	1.0 (7.55)
Change at Day 131: DBP	-1.3 (3.01)	-1.7 (8.48)	-3.4 (8.99)	0.0 (5.34)
Change at pre-dose Day 140: DBP	-4.3 (10.15)	2.5 (11.20)	1.0 (14.52)	-0.4 (5.32)
Change at 1 H post-dose Day 140: DBP	-2.7 (7.87)	4.2 (10.82)	-1.3 (10.19)	-2.2 (6.22)
Change at 4 H post dose Day 140: DBP	-6.3 (8.24)	3.3 (9.20)	-6.5 (8.24)	-2.2 (5.22)
Change at 24 H post dose Day 141: DBP	-4.7 (4.13)	2.2 (12.04)	-4.5 (7.09)	0.6 (6.73)
Change at Day 154: DBP	2.5 (8.85)	-5.5 (5.79)	-4.0 (4.97)
Change at Day 168: DBP	-2.2 (6.88)	0.0 (11.51)	-4.8 (7.00)	1.0 (5.92)
Change at Day 224/ET: DBP	-0.8 (8.50)	1.0 (8.00)	-3.0 (4.52)	-0.5 (5.96)
Change at Day 304/ET: DBP	1.3 (11.57)	1.2 (16.41)	2.8 (4.99)

24. Secondary Outcome

Title	Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Pulse Rate
Time Frame	Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo matching to PF-04382923 in dosages ranging from 5 to 15 mg/kg as intravenous infusion over 60 minutes followed by a 5 mL flush of 0.9% Sodium Chloride Injection, every 4 weeks, for a total of up to 6 doses.
Measure Participants	6	6	6	6
Baseline	64.2 (6.40)	62.8 (4.40)	66.5 (6.53)	66.7 (5.01)
Change at 1H post-dose Day 1	1.7 (2.66)	-1.8 (4.40)	-4.2 (5.46)	1.0 (8.83)
Change at 4 H post-dose Day 1	3.5 (6.25)	1.2 (5.81)	-2.3 (7.50)	4.0 (7.77)
Change at 24 H post-dose Day 2	0.8 (2.71)	1.5 (1.97)	-2.0 (3.74)	3.8 (6.40)
Change at Day 7	4.5 (3.67)	3.3 (3.08)	-4.2 (5.42)	4.2 (5.95)
Change at Day 14	1.2 (2.04)	4.3 (7.39)	0.3 (4.59)	6.0 (6.93)
Change at Day 19	2.5 (5.92)	7.8 (7.60)	0.0 (2.45)	1.0 (5.76)
Change at pre-dose Day 28	0.2 (5.53)	2.3 (5.32)	-1.5 (5.72)	-1.2 (2.71)
Change at 4-8 H post-dose Day 28	6.5 (10.15)	2.2 (2.56)	-2.8 (4.32)	0.3 (12.04)
Change at Day 45	3.5 (2.17)	2.3 (4.03)	5.2 (7.26)	-3.0 (5.73)
Change at pre-dose Day 56	1.2 (2.99)	1.5 (4.37)	-3.7 (5.13)	2.0 (5.51)
Change at 4-8 H post-dose day 56	3.0 (4.69)	2.3 (4.13)	1.6 (10.14)	6.0 (9.08)
Change at Day 75	1.5 (4.64)	5.5 (6.19)	8.0 (8.12)	6.8 (8.90)
Change at pre-dose Day 84	2.3 (3.83)	4.0 (3.10)	-1.8 (4.17)	2.2 (7.09)
Change at 4-8 H post-dose Day 84	-0.3 (5.89)	1.8 (4.31)	-2.7 (7.76)	4.2 (5.12)
Change at Day 103	2.2 (2.04)	2.5 (4.09)	1.3 (1.63)	6.0 (5.29)
Change at pre-dose Day 112	-0.8 (4.02)	1.5 (3.33)	-0.2 (4.26)	0.2 (5.02)
Change at 4-8 H post-dose Day 112	1.8 (2.86)	3.3 (5.05)	-2.2 (3.19)	-1.6 (0.89)
Change at Day 131	1.8 (4.07)	7.2 (7.55)	2.8 (13.07)	1.8 (6.94)
Change at pre-dose Day 140	2.5 (3.99)	2.8 (4.07)	-0.8 (4.79)	3.2 (3.27)
Change at 1 H post-dose Day 140	-0.5 (4.37)	0.8 (5.53)	-4.5 (6.83)	-3.2 (9.09)
Change at 4 H post dose Day 140.	3.2 (4.83)	4.0 (8.94)	-2.8 (6.91)	-1.0 (10.20)
Change at 24 H post dose Day 141	1.0 (3.22)	8.7 (3.88)	-2.0 (6.10)	6.4 (4.77)
Change at Day 154	9.2 (3.82)	0.5 (8.73)	13.5 (5.00)
Change at Day 168	1.7 (1.86)	-0.5 (4.89)	-6.8 (5.42)	4.8 (7.56)
Change at Day 224/ET	-1.2 (6.94)	0.3 (5.01)	-0.7 (5.99)	0.5 (4.55)
Change at Day 304/ET	1.2 (5.88)	-0.2 (2.56)	2.0 (5.66)

25. Secondary Outcome

Title	Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Temperature
Time Frame	Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo matching to PF-04382923 in dosages ranging from 5 to 15 mg/kg as intravenous infusion over 60 minutes followed by a 5 mL flush of 0.9% Sodium Chloride Injection, every 4 weeks, for a total of up to 6 doses.
Measure Participants	6	6	6	6
Baseline	36.40 (0.228)	36.72 (0.256)	36.87 (0.082)	36.72 (0.397)
Change at 1H post-dose Day 1	0.30 (0.405)	0.10 (0.253)	-0.10 (0.190)	0.08 (0.183)
Change at 4 H post-dose Day 1	0.18 (0.571)	0.08 (0.133)	0.03 (0.207)	0.17 (0.327)
Change at 24 H post-dose Day 2	0.22 (0.204)	0.12 (0.232)	-0.32 (0.371)	-0.08 (0.515)
Change at Day 7	0.15 (0.226)	0.05 (0.315)	-0.40 (0.405)	0.00 (0.276)
Change at Day 14	0.37 (0.350)	-0.03 (0.327)	0.08 (0.117)	0.05 (0.243)
Change at Day 19	0.43 (0.234)	-0.12 (0.271)	0.04 (0.288)	-0.02 (0.183)
Change at pre-dose Day 28	0.18 (0.204)	-0.10 (0.283)	-0.02 (0.172)	-0.17 (0.294)
Change at 4-8 H post-dose Day 28	0.28 (0.172)	0.15 (0.339)	0.00 (0.158)	0.03 (0.186)
Change at Day 45	0.13 (0.413)	0.12 (0.483)	-0.06 (0.195)	0.03 (0.516)
Change at pre-dose Day 56	0.05 (0.476)	0.08 (0.366)	0.03 (0.175)	0.07 (0.350)
Change at 4-8 H post-dose day 56	0.22 (0.313)	0.13 (0.273)	0.12 (0.084)	0.00 (0.436)
Change at Day 75	-0.15 (0.437)	0.07 (0.333)	-0.06 (0.279)	-0.28 (0.383)
Change at pre-dose Day 84	-0.03 (0.216)	-0.03 (0.320)	0.02 (0.147)	-0.10 (0.400)
Change at 4-8 H post-dose Day 84	-0.13 (0.665)	0.00 (0.167)	0.03 (0.103)	0.10 (0.274)
Change at Day 103	0.05 (0.394)	-0.08 (0.462)	-0.10 (0.219)	-0.06 (0.251)
Change at pre-dose Day 112	-0.08 (0.512)	0.12 (0.279)	-0.15 (0.274)	-0.20 (0.292)
Change at 4-8 H post-dose Day 112	0.03 (0.437)	0.12 (0.387)	-0.22 (0.293)	0.06 (0.336)
Change at Day 131	0.18 (0.387)	0.02 (0.458)	-0.14 (0.288)	-0.04 (0.261)
Change at pre-dose Day 140	0.10 (0.352)	-0.05 (0.432)	-0.07 (0.207)	-0.02 (0.311)
Change at 1 H post-dose Day 140	0.02 (0.496)	0.08 (0.407)	-0.03 (0.197)	-0.30 (0.224)
Change at 4 H post dose Day 140	0.23 (0.197)	0.05 (0.428)	-0.12 (0.248)	-0.14 (0.270)
Change at 24 H post dose Day 141	0.00 (0.210)	0.08 (0.248)	-0.18 (0.183)	-0.14 (0.365)
Change at Day 154	0.07 (0.266)	-0.25 (0.414)	0.00 (0.141)
Change at Day 168	0.27 (0.459)	-0.12 (0.293)	-0.18 (0.264)	0.12 (0.192)
Change at Day 224/ET	0.03 (0.446)	0.07 (0.234)	-0.07 (0.288)	0.03 (0.472)
Change at Day 304/ET	-0.10 (0.283)	-0.10 (0.167)	-0.08 (0.150)

26. Secondary Outcome

Title	Change From Baseline in Vital Signs at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 112, 131, 140, 141, 154, 168, 224, 304/ET: Weight
Time Frame	Baseline, 1 and 4 H post-dose on Day 1; 24 H post-dose on Days 2 and 141; pre-dose and 4 - 8 H post-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 7, 14, 19, 45, 75, 103;131, 141, 154 168, 224 and 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline	81.74 (9.975)	85.85 (8.443)	78.58 (12.497)	80.14 (21.430)
Change at Day 19	0.25 (0.709)	-0.05 (1.588)	0.09 (1.330)	0.93 (0.945)
Change at Day 28	0.46 (0.749)	-0.12 (2.098)	0.02 (1.172)	0.29 (0.661)
Change at Day 45	0.71 (1.654)	-0.49 (2.298)	0.52 (0.899)	0.36 (1.219)
Change at Day 56	0.72 (1.425)	-0.99 (2.371)	-1.21 (2.942)	0.52 (0.616)
Change at Day 75	0.60 (1.464)	-0.46 (3.267)	0.48 (0.883)	0.98 (0.641)
Change at Day 84	0.63 (1.538)	-0.54 (3.194)	-0.16 (0.943)	0.99 (1.050)
Change at Day 103	-0.60 (4.787)	-0.75 (3.213)	0.22 (1.249)	1.23 (1.490)
Change at Day 112	0.67 (1.118)	0.05 (3.638)	-0.05 (0.731)	1.43 (1.097)
Change at Day 131	1.35 (1.354)	-0.43 (4.197)	-0.08 (0.646)	1.67 (1.159)
Change at Day 140	1.06 (0.833)	-0.36 (4.233)	-0.46 (1.248)	1.37 (1.708)
Change at Day 154	-3.78 (8.246)	-0.57 (1.301)	1.03 (1.464)
Change at Day 168	1.74 (2.723)	-1.35 (4.393)	-0.84 (1.237)	1.26 (1.312)
Change at Day 224/ ET	0.85 (0.976)	-1.97 (4.284)	1.49 (4.376)	1.42 (1.679)
Change at Day 304/ET	0.71 (6.545)	3.04 (4.327)	0.60 (0.678)

27. Secondary Outcome

Title	Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Description	Criteria for changes in ECG (12-lead) were defined as: PR interval >=220 millisecond (msec) and increase of >=20 msec; QRS interval >=120 msec; QT interval corrected using the Bazett's formula (QTcB) >=500 msec; Maximum Change from Baseline in QTcF at Borderline >=30 msec to <60 msec and Prolonged >=60 msec.
Time Frame	Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET

Outcome Measure Data

Analysis Population Description

Safety analysis set included all randomized participants who received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline: RR	939.28 (124.486)	962.44 (117.246)	918.39 (101.325)	928.33 (117.701)
Change at 1 H post-dose Day 1: RR	4.06 (45.449)	24.94 (70.632)	79.11 (89.729)	-21.22 (136.555)
Change at 4 H post-dose Day 1: RR	-36.28 (38.148)	-34.22 (82.327)	22.33 (115.576)	-54.11 (94.978)
Change at pre-dose Day 28: RR	29.56 (40.059)	0.39 (53.575)	69.44 (91.732)	49.00 (78.316)
Change at pre-dose Day 56: RR	5.39 (61.533)	-19.78 (32.654)	74.78 (98.804)	8.83 (65.440)
Change at pre-dose Day 84: RR	-7.61 (53.735)	-12.78 (56.646)	57.11 (102.514)	-51.67 (186.668)
Change at pre-dose Day 112: RR	30.56 (23.478)	-24.11 (63.637)	34.94 (77.744)	-44.87 (82.091)
Change at pre-dose Day 140: RR	-6.39 (43.272)	-39.89 (85.486)	26.56 (91.107)	-9.60 (51.462)
Change at 1 H post-dose Day 140: RR	-6.78 (120.518)	-16.83 (58.974)	80.44 (104.487)	42.60 (150.052)
Change at 4 H post dose Day 140: RR	-44.61 (76.284)	-66.17 (86.676)	52.17 (86.145)	5.13 (166.054)
Change at Day 168: RR	-33.11 (80.934)	-31.78 (27.507)	60.44 (122.291)	-28.67 (70.982)
Change at Day 224/ET: RR	21.72 (77.289)	8.89 (58.224)	-22.72 (99.733)	56.50 (78.870)
Change at Day 304/ET: RR	32.39 (70.600)	-9.22 (80.263)	-11.92 (122.446)
Baseline: PR	170.78 (23.268)	190.00 (38.006)	167.89 (25.711)	166.11 (41.177)
Change at 1 H post-dose Day 1: PR	-4.22 (13.589)	-4.33 (9.407)	-7.11 (12.261)	-2.67 (6.902)
Change at 4 H post-dose Day 1: PR	-1.33 (9.762)	-4.89 (6.898)	-6.33 (7.563)	-2.89 (6.362)
Change at pre-dose Day 28: PR	-2.78 (11.711)	1.00 (10.673)	28.44 (84.486)	3.89 (12.245)
Change at pre-dose Day 56: PR	-6.78 (9.270)	0.33 (15.842)	-11.47 (22.912)	12.22 (23.512)
Change at pre-dose Day 84: PR	0.22 (6.885)	-8.33 (18.426)	-0.67 (1.944)	11.73 (32.392)
Change at pre-dose Day 112: PR	-0.78 (12.567)	-3.33 (18.086)	-13.56 (22.134)	16.53 (26.764)
Change at pre-dose Day 140: PR	2.33 (8.892)	-1.11 (14.052)	-4.22 (5.311)	11.33 (23.636)
Change at 1 H post-dose Day 140: PR	-3.33 (7.760)	-1.56 (11.938)	-4.67 (14.569)	16.27 (22.229)
Change at 4 H post dose Day 140: PR	-4.33 (9.177)	2.00 (8.316)	-7.89 (11.262)	21.87 (28.757)
Change at Day 168: PR	-4.11 (8.405)	-7.00 (12.994)	-2.56 (5.154)	-1.50 (10.932)
Change at Day 224/ET: PR	-7.11 (14.090)	-1.00 (15.468)	-7.89 (7.061)	14.13 (24.214)
Change at Day 304/ET: PR	-3.00 (19.066)	-17.22 (21.935)	16.33 (21.709)
Baseline: QRS	87.11 (5.036)	91.44 (8.352)	97.89 (22.444)	100.33 (24.858)
Change at 1 H post-dose Day 1: QRS	-2.67 (4.881)	-1.56 (3.417)	-2.33 (2.789)	0.78 (1.760)
Change at 4 H post-dose Day 1: QRS	-1.78 (4.856)	-1.67 (2.692)	0.44 (2.373)	0.78 (3.410)
Change at pre-dose Day 28: QRS	1.56 (4.375)	-1.44 (3.410)	-0.89 (2.656)	-0.33 (2.261)
Change at pre-dose Day 56: QRS	-1.44 (2.083)	0.22 (5.054)	1.78 (2.722)	-2.67 (6.037)
Change at pre-dose Day 84: QRS	-2.11 (3.331)	-0.11 (6.217)	6.78 (22.333)	1.60 (9.541)
Change at pre-dose Day 112: QRS	-3.11 (7.101)	1.56 (4.593)	5.11 (20.149)	0.80 (4.840)
Change at pre-dose Day 140: QRS	-2.67 (4.638)	1.22 (5.439)	0.33 (2.883)	-0.40 (4.017)
Change at 1 H post-dose Day 140: QRS	-2.56 (3.538)	0.67 (6.613)	1.22 (2.083)	0.40 (4.681)
Change at 4 H post dose Day 140: QRS	-2.22 (3.202)	-0.22 (4.456)	-0.44 (1.440)	2.53 (5.586)
Change at Day 168: QRS	-4.44 (5.106)	1.89 (5.340)	2.11 (4.530)	0.00 (4.922)
Change at Day 224/ET: QRS	-2.44 (6.017)	0.22 (3.569)	9.78 (26.712)	1.00 (2.692)
Change at Day 304/ET: QRS	1.22 (6.895)	-2.56 (1.760)	5.83 (4.631)
Baseline: QT	405.00 (25.174)	422.00 (29.835)	408.56 (30.560)	401.78 (31.932)
Change at 1H post-dose Day 1: QT	1.22 (14.270)	2.22 (11.713)	14.22 (14.845)	0.78 (26.346)
Change at 4 H post-dose Day 1: QT	-3.78 (18.493)	-13.44 (19.018)	4.67 (29.796)	1.56 (32.457)
Change at pre-dose Day 28: QT	-1.33 (13.367)	-11.33 (17.420)	11.11 (14.228)	4.89 (18.290)
Change at pre-dose Day 56: QT	-2.33 (11.939)	-8.67 (10.302)	18.44 (31.865)	8.22 (10.221)
Change at pre-dose Day 84: QT	-2.33 (15.769)	-11.33 (13.914)	14.11 (26.319)	10.27 (28.482)
Change at pre-dose Day 112: QT	-1.00 (5.379)	-9.33 (17.420)	5.44 (13.607)	19.07 (35.345)
Change at pre-dose Day 140: QT	-3.44 (12.274)	-6.00 (14.092)	11.89 (18.621)	7.47 (25.304)
Change at 1 H post-dose Day 140: QT	-4.67 (24.909)	-18.00 (35.700)	22.33 (22.170)	19.33 (28.091)
Change at 4 H post dose Day 140: QT	-10.22 (12.174)	-13.00 (17.006)	19.67 (14.340)	11.33 (35.308)
Change at Day 168: QT	-13.00 (17.255)	-5.67 (11.939)	16.44 (36.302)	4.27 (26.594)
Change at Day 224/ET: QT	-1.67 (6.782)	-9.67 (12.442)	-1.22 (27.995)	19.22 (22.225)
Change at Day 304/ET: QT	-1.67 (16.896)	-8.56 (31.792)	9.33 (36.127)
Baseline: QTcB	418.56 (13.605)	430.67 (20.976)	426.28 (18.370)	417.11 (17.539)
Change at 1 H post-dose Day 1: QTcB	0.39 (4.823)	-3.50 (6.483)	-2.67 (12.006)	5.81 (17.269)
Change at 4 H post-dose Day 1: QTcB	4.44 (13.274)	-6.67 (14.188)	-0.11 (6.811)	13.50 (29.257)
Change at pre-dose Day 28: QTcB	-6.39 (17.989)	-12.50 (14.442)	-2.94 (18.639)	-5.94 (5.953)
Change at pre-dose Day 56: QTcB	-2.06 (16.679)	-4.67 (9.920)	1.56 (15.450)	5.39 (19.841)
Change at pre-dose Day 84: QTcB	-0.89 (8.516)	-9.33 (16.350)	2.22 (21.281)	23.07 (32.116)
Change at pre-dose Day 112: QTcB	-6.89 (9.135)	-4.33 (8.899)	-1.11 (9.660)	29.07 (42.361)
Change at pre-dose Day 140: QTcB	-2.11 (6.493)	3.17 (11.201)	6.94 (6.641)	9.33 (22.955)
Change at 1 H post-dose Day 140: QTcB	-0.61 (9.855)	-14.78 (38.322)	4.72 (10.794)	11.33 (18.318)
Change at 4 H post dose Day 140: QTcB	0.72 (9.525)	1.83 (9.697)	9.06 (11.144)	11.80 (20.895)
Change at Day 168: QTcB	-6.39 (18.637)	1.33 (13.471)	4.06 (10.810)	10.07 (21.177)
Change at Day 224/ET: QTcB	-5.39 (11.496)	-12.33 (13.105)	3.72 (14.188)	6.72 (17.425)
Change at Day 304/ET: QTcB	-9.5 (15.812)	-6.28 (17.655)	13.17 (8.813)

28. Secondary Outcome

Title	Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET
Time Frame	Baseline, 1 and 4 H post-dose on Day 1; pre-dose on Days 28, 56, 84, 112; pre-dose and 1, 4 H post-dose on Day 140; Day 168, 224 and 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline	64.94 (9.318)	63.17 (7.327)	66.06 (7.295)	65.44 (7.556)
Change at 1 H post-dose Day 1	-0.33 (3.026)	-1.67 (4.142)	-5.44 (6.527)	2.72 (10.603)
Change at 4 H post-dose Day 1	2.28 (2.752)	2.11 (5.188)	-1.72 (8.045)	4.00 (7.226)
Change at pre-dose Day 28	-1.78 (2.562)	-0.17 (3.475)	-4.39 (5.463)	-3.78 (5.496)
Change at pre-dose Day 56	0.39 (4.096)	1.17 (1.810)	-4.89 (7.290)	-1.11 (4.617)
Change at pre-dose Day 84	0.22 (3.410)	0.50 (3.378)	-3.72 (6.191)	4.00 (12.243)
Change at pre-dose Day 112	-1.78 (1.559)	1.33 (4.580)	-1.89 (3.959)	3.00 (6.342)
Change at pre-dose Day 140	0.50 (2.606)	2.89 (5.556)	-1.39 (6.591)	0.93 (3.919)
Change at 1 H post-dose Day 140	2.61 (11.432)	1.17 (3.650)	-5.22 (6.649)	-2.13 (10.038)
Change at 4 H post dose Day 140	3.67 (5.578)	5.11 (6.869)	-3.61 (5.752)	0.47 (12.613)
Change at Day 168	2.22 (5.419)	2.00 (1.687)	-3.56 (7.745)	2.20 (5.316)
Change at Day 224/ET	-0.61 (5.031)	-0.67 (4.279)	1.11 (7.067)	-3.44 (5.730)
Change at Day 304/ET	-2.50 (4.451)	0.94 (6.220)	3.08 (9.094)

29. Secondary Outcome

Title	Change From Baseline in Bilirubin, Direct Bilirubin, Blood Urea Nitrogen, Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol, Triglycerides, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Description	Following parameters were analyzed for laboratory examination: Bilirubin, Direct Bilirubin, Blood Urea Nitrogen(BUN), Creatinine, Uric Acid, Calcium, Phosphate, Glucose, Cholesterol (CL)(Fasting), Triglycerides (Fasting) (TG), Immunoglobulin G (Ig G), Immunoglobulin A (Ig A), Immunoglobulin M (Ig M)
Time Frame	Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point. Categories with at least 1 non-zero data have been provided below.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline: Bilirubin	0.48 (0.147)	0.58 (0.422)	0.47 (0.234)	0.52 (0.204)
Change at Day 28: Bilirubin	-0.05 (0.122)	-0.12 (0.264)	0.08 (0.435)	-0.10 (0.126)
Change at Day 56: Bilirubin	0.02 (0.133)	-0.07 (0.121)	0.25 (0.409)	-0.07 (0.121)
Change at Day 84: Bilirubin	-0.03 (0.082)	-0.03 (0.250)	0.12 (0.133)	-0.10 (0.122)
Change at Day 112: Bilirubin	-0.10 (0.141)	-0.08 (0.325)	0.20 (0.276)	-0.10 (0.158)
Change at Day 140: Bilirubin	-0.07 (0.082)	-0.02 (0.343)	0.20 (0.316)	-0.10 (0.158)
Change at Day 168: Bilirubin	-0.02 (0.075)	0.00 (0.200)	0.17 (0.423)	-0.08 (0.192)
Change at Day 224/ET: Bilirubin	-0.07 (0.082)	0.00 (0.210)	0.02 (0.133)	-0.07 (0.163)
Change at Day 304/ET: Bilirubin	0.05 (0.105)	0.20 (0.415)	-0.05 (0.100)
Baseline: Direct Bilirubin	0.15 (0.055)	0.17 (0.082)	0.15 (0.055)	0.13 (0.052)
Change at Day 28: Direct Bilirubin	-0.03 (0.052)	-0.03 (0.052)	0.00 (0.082)	-0.02 (0.041)
Change at Day 56: Direct Bilirubin	0.00 (0.063)	0.00 (0.000)	0.02 (0.098)	0.00 (0.071)
Change at Day 84: Direct Bilirubin	0.00 (0.063)	-0.02 (0.041)	0.00 (0.063)	0.00 (0.000)
Change at Day 112: Direct Bilirubin	-0.02 (0.075)	-0.02 (0.041)	0.00 (0.071)	0.02 (0.045)
Change at Day 140: Direct Bilirubin	-0.03 (0.052)	-0.02 (0.041)	0.00 (0.063)	0.00 (0.000)
Change at Day 168: Direct Bilirubin	-0.02 (0.041)	-0.02 (0.041)	0.02 (0.098)	0.02 (0.045)
Change at Day 224/ET: Direct Bilirubin	-0.02 (0.075)	0.00 (0.000)	0.00 (0.000)	0.00 (0.063)
Change at Day 304/ET: Direct Bilirubin	0.00 (0.000)	0.02 (0.098)	0.03 (0.050)
Baseline: BUN	18.7 (5.01)	15.5 (3.89)	18.8 (3.87)	23.3 (8.33)
Change at Day 28: BUN	-0.3 (3.14)	-0.2 (2.64)	0.5 (7.14)	1.5 (3.73)
Change at Day 56: BUN	-2.0 (2.10)	-1.2 (4.62)	2.7 (1.63)	0.0 (4.52)
Change at Day 84: BUN	1.3 (4.32)	1.3 (3.78)	-0.2 (5.98)	-3.6 (7.02)
Change at Day 112: BUN	-0.2 (5.08)	-0.5 (2.74)	1.7 (4.27)	-1.0 (7.62)
Change at Day 140: BUN	1.0 (4.60)	-0.2 (4.07)	1.3 (2.42)	-1.6 (5.41)
Change at Day 168: BUN	0.0 (2.45)	0.5 (3.51)	1.0 (3.46)	-1.2 (6.76)
Change at Day 224/ET: BUN	1.2 (2.14)	1.3 (2.80)	0.8 (2.93)	-0.5 (8.87)
Change at Day 304/ET: BUN	1.5 (2.59)	2.3 (4.63)	-3.5 (6.35)
Baseline: Creatinine	0.918 (0.2322)	0.955 (0.0750)	0.917 (0.1657)	1.105 (0.3136)
Change at Day 28: Creatinine	0.008 (0.1121)	-0.032 (0.0708)	0.108 (0.1024)	-0.007 (0.1371)
Change at Day 56: Creatinine	0.047 (0.0880)	0.000 (0.1163)	0.037 (0.0766)	-0.013 (0.1317)
Change at Day 84: Creatinine	0.053 (0.0755)	0.038 (0.1196)	0.042 (0.0891)	-0.038 (0.1512)
Change at Day 112: Creatinine	0.043 (0.1179)	0.008 (0.0924)	0.082 (0.1389)	-0.024 (0.1747)
Change at Day 140: Creatinine	0.055 (0.1710)	-0.020 (0.1271)	0.035 (0.0742)	0.002 (0.1956)
Change at Day 168: Creatinine	0.020 (0.1316)	-0.045 (0.0922)	0.113 (0.1088)	-0.018 (0.2525)
Change at Day 224/ET: Creatinine	-0.002 (0.1321)	0.012 (0.1297)	0.047 (0.1196)	0.015 (0.2118)
Change at Day 304/ET: Creatinine	0.008 (0.1072)	0.092 (0.0909)	-0.045 (0.3023)
Baseline: Uric Acid	4.87 (1.172)	5.97 (1.335)	5.77 (1.039)	5.58 (1.238)
Change at Day 28: Uric Acid	-0.05 (0.539)	-0.25 (0.176)	0.03 (0.640)	0.22 (0.471)
Change at Day 56: Uric Acid	-0.05 (0.497)	-0.25 (0.383)	0.00 (0.566)	-0.07 (0.463)
Change at Day 84: Uric Acid	-0.08 (0.722)	0.07 (0.327)	-0.12 (0.943)	-0.48 (0.487)
Change at Day 112: Uric Acid	-0.32 (0.571)	0.02 (0.694)	0.32 (0.804)	0.10 (0.997)
Change at Day 140: Uric Acid	-0.05 (0.641)	-0.05 (0.701)	0.18 (0.828)	0.32 (0.785)
Change at Day 168: Uric Acid	0.23 (0.855)	-0.03 (0.698)	0.28 (0.422)	0.22 (0.779)
Change at Day 224/ET: Uric Acid	0.62 (1.072)	0.07 (0.662)	0.17 (0.836)	0.48 (0.933)
Change at Day 304/ET: Uric Acid	0.32 (0.677)	-0.07 (1.143)	-0.10 (0.510)
Baseline: Calcium	9.62 (0.248)	9.62 (0.458)	9.60 (0.358)	9.76 (0.301)
Change at Day 28: Calcium	0.00 (0.335)	-0.22 (0.264)	-0.02 (0.395)	-0.37 (0.301)
Change at Day 56: Calcium	0.17 (0.550)	-0.07 (0.344)	0.10 (0.540)	-0.22 (0.471)
Change at Day 84: Calcium	0.10 (0.369)	-0.03 (0.388)	-0.02 (0.387)	-0.38 (0.396)
Change at Day 112: Calcium	-0.17 (0.361)	-0.07 (0.356)	0.08 (0.488)	-0.26 (0.550)
Change at Day 140: Calcium	0.13 (0.367)	-0.17 (0.378)	-0.07 (0.472)	-0.16 (0.498)
Change at Day 168: Calcium	-0.15 (0.638)	-0.32 (0.306)	-0.17 (0.327)	-0.30 (0.660)
Change at Day 224/ET: Calcium	0.12 (0.279)	-0.27 (0.393)	0.05 (0.509)	-0.08 (0.512)
Change at Day 304/ET: Calcium	-0.15 (0.446)	0.23 (0.484)	0.03 (0.377)
Baseline: Phosphate	3.20 (0.583)	3.48 (0.376)	3.62 (0.637)	3.28 (0.717)
Change at Day 28: Phosphate	0.22 (0.417)	0.08 (0.382)	0.18 (0.310)	0.22 (0.508)
Change at Day 56: Phosphate	-0.03 (0.273)	0.02 (0.194)	0.25 (0.539)	0.22 (0.598)
Change at Day 84: Phosphate	0.27 (0.489)	0.03 (0.197)	0.12 (0.512)	0.12 (0.466)
Change at Day 112: Phosphate	0.27 (0.308)	0.17 (0.197)	0.03 (0.356)	0.38 (0.497)
Change at Day 140: Phosphate	0.32 (0.360)	0.00 (0.369)	-0.27 (0.575)	0.58 (0.554)
Change at Day 168: Phosphate	0.17 (0.459)	-0.12 (0.331)	0.15 (0.418)	0.36 (0.581)
Change at Day 224/ET: Phosphate	0.13 (0.472)	-0.10 (0.456)	0.15 (0.521)	0.30 (0.863)
Change at Day 304/ET: Phosphate	0.25 (0.217)	0.12 (0.598)	0.15 (0.412)
Baseline: Glucose	93.8 (11.20)	92.5 (7.84)	90.0 (13.97)	95.8 (9.99)
Change at Day 28: Glucose	22.8 (48.16)	3.8 (9.77)	7.0 (5.48)	3.3 (14.39)
Change at Day 56: Glucose	1.7 (6.19)	3.7 (7.42)	6.5 (15.67)	0.5 (11.04)
Change at Day 84: Glucose	-2.0 (1.41)	7.2 (12.56)	7.5 (11.47)	7.8 (13.35)
Change at Day 112: Glucose	4.7 (5.28)	7.3 (12.13)	9.2 (11.58)	3.6 (10.67)
Change at Day 140: Glucose	6.8 (4.88)	6.3 (12.04)	17.7 (7.69)	11.0 (14.61)
Change at Day 168: Glucose	-1.0 (6.42)	3.2 (6.11)	12.5 (14.79)	17.6 (32.65)
Change at Day 224/ET: Glucose	0.7 (6.28)	3.3 (5.85)	8.5 (12.85)	7.2 (28.03)
Change at Day 304/ET: Glucose	5.8 (12.16)	3.8 (15.69)	20.3 (50.70)
Baseline: CL (fasting)	191.7 (20.34)	188.7 (60.01)	196.5 (48.19)	194.2 (33.71)
Change at Day 28: CL (fasting)	-9.0 (13.28)	2.7 (15.12)	-10.8 (12.63)	13.3 (27.09)
Change at Day 56: CL (fasting)	12.3 (14.19)	-10.2 (15.79)	1.7 (12.89)	8.0 (42.82)
Change at Day 84: CL (fasting)	0.0 (8.02)	1.5 (9.57)	-2.2 (10.80)	-2.4 (23.20)
Change at Day 112: CL (fasting)	-6.5 (35.23)	-5.8 (7.99)	0.7 (19.05)	-7.2 (18.86)
Change at Day 140: CL (fasting)	-2.5 (17.13)	0.3 (15.23)	4.2 (10.67)	-5.4 (33.06)
Change at Day 168: CL (fasting)	-0.8 (26.54)	-2.5 (8.57)	-12.5 (21.68)	13.0 (37.90)
Change at Day 224/ET: CL (fasting)	-4.7 (19.79)	0.2 (10.72)	-11.8 (24.34)	7.2 (40.49)
Change at Day 304/ET: CL (fasting)	1.3 (19.28)	-3.5 (13.88)	-1.3 (29.34)
Baseline: TG (fasting)	141.7 (47.32)	138.5 (58.95)	110.5 (41.40)	195.2 (149.85)
Change at Day 28: TG (fasting)	-23.2 (35.44)	4.0 (68.07)	-9.3 (34.91)	-8.0 (37.31)
Change at Day 56: TG (fasting)	4.2 (63.29)	-24.7 (57.41)	-8.2 (23.51)	-49.5 (124.64)
Change at Day 84: TG (fasting)	2.2 (38.57)	-18.0 (43.32)	-19.7 (18.22)	-98.4 (140.73)
Change at Day 112: TG (fasting)	6.0 (73.16)	-16.5 (32.31)	-2.8 (23.76)	-89.0 (146.53)
Change at Day 140: TG (fasting)	-15.0 (45.79)	-13.7 (50.39)	-7.5 (29.13)	-67.6 (84.14)
Change at Day 168: TG (fasting)	-11.5 (43.72)	-7.3 (26.30)	-4.2 (24.13)	-52.2 (151.28)
Change at Day 224/ET: TG (fasting)	-24.5 (46.00)	-18.0 (54.98)	-13.8 (22.68)	-58.0 (77.36)
Change at Day 304/ET: TG (fasting)	-18.5 (31.17)	0.5 (26.94)	-42.0 (168.16)
Baseline: lg G	840.5 (171.08)	793.0
Change at Day 28: lg G	42.7 (26.63)
Change at Day 84: lg G	69.7 (65.83)	-30.0
Change at Day 140: lg G	41.8 (72.02)	-40.0
Baseline: lg A	257.3 (108.27)	299.0
Change at Day 28: lg A	7.0 (7.55)
Change at Day 84: lg A	-10.0 (14.56)	-25.0
Change at Day 140: lg A	-4.2 (26.36)	-25.0
Baseline: lg M	101.0 (60.79)	58.0
Change at Day 28: lg M	9.7 (8.74)
Change at Day 84: lg M	4.7 (7.06)	-6.0
Change at Day 140: lg M	8.2 (19.69)	-9.0

30. Secondary Outcome

Title	Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Time Frame	Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline: Protein	7.07 (0.273)	6.93 (0.273)	6.97 (0.234)	6.77 (0.225)
Change at Day 28: Protein	-0.25 (0.274)	-0.25 (0.302)	-0.23 (0.386)	-0.15 (0.266)
Change at Day 56: Protein	-0.08 (0.392)	-0.25 (0.207)	-0.03 (0.266)	-0.10 (0.434)
Change at Day 84: Protein	-0.03 (0.216)	0.02 (0.293)	0.02 (0.407)	-0.06 (0.207)
Change at Day 112: Protein	-0.25 (0.339)	-0.02 (0.343)	-0.05 (0.383)	-0.06 (0.378)
Change at Day 140: Protein	-0.28 (0.271)	-0.17 (0.225)	-0.05 (0.259)	-0.36 (0.305)
Change at Day 168: Protein	-0.33 (0.273)	-0.13 (0.250)	-0.23 (0.207)	0.00 (0.529)
Change at Day 224/ET: Protein	-0.18 (0.354)	-0.17 (0.383)	0.03 (0.258)	0.35 (0.404)
Change at Day 304/ET: Protein	-0.03 (0.339)	0.02 (0.319)	0.10 (0.572)
Baseline: Albumin	4.23 (0.301)	4.48 (0.194)	4.43 (0.121)	4.28 (0.172)
Change at Day 28: Albumin	-0.10 (0.190)	-0.12 (0.256)	-0.13 (0.310)	-0.03 (0.175)
Change at Day 56: Albumin	0.08 (0.319)	-0.13 (0.151)	0.02 (0.147)	-0.12 (0.331)
Change at Day 84: Albumin	0.02 (0.098)	-0.02 (0.286)	0.02 (0.183)	-0.06 (0.152)
Change at Day 112: Albumin	-0.12 (0.313)	-0.07 (0.197)	0.02 (0.117)	-0.08 (0.277)
Change at Day 140: Albumin	-0.08 (0.133)	-0.15 (0.152)	0.02 (0.232)	-0.14 (0.321)
Change at Day 168: Albumin	-0.17 (0.175)	-0.10 (0.155)	-0.08 (0.160)	0.00 (0.354)
Change at Day 224/ET: Albumin	0.03 (0.175)	-0.05 (0.362)	-0.02 (0.075)	0.12 (0.256)
Change at Day 304/ET: Albumin	-0.08 (0.264)	0.00 (0.167)	0.13 (0.377)
Baseline: Hemoglobin	14.07 (1.392)	14.28 (0.662)	13.93 (1.007)	13.80 (1.669)
Change at Day 28: Hemoglobin	-0.36 (0.493)	-0.38 (0.337)	-0.44 (1.029)	-0.57 (0.468)
Change at Day 56: Hemoglobin	-0.03 (0.622)	-0.68 (0.356)	0.17 (0.308)	-0.58 (0.960)
Change at Day 84: Hemoglobin	-0.28 (0.471)	0.08 (0.576)	0.18 (0.523)	-0.75 (0.387)
Change at Day 112: Hemoglobin	-0.18 (0.627)	-0.12 (0.714)	-0.33 (0.905)	-0.80 (0.592)
Change at Day 140: Hemoglobin	-0.48 (0.293)	-0.10 (0.352)	-0.25 (0.991)	-0.66 (0.581)
Change at Day 168: Hemoglobin	-0.42 (0.462)	-0.25 (0.451)	-0.55 (0.819)	-0.58 (0.507)
Change at Day 224/ET: Hemoglobin	-0.12 (0.585)	0.00 (0.525)	0.15 (0.709)	-0.12 (0.769)
Change at Day 304/ET: Hemoglobin	0.28 (1.1136)	0.05 (0.565)	-0.55 (1.473)

31. Secondary Outcome

Title	Change From Baseline in Laboratory Assessments: Aspartate Aminotransferase, Creatine Kinase, Alanine Aminotransferase, Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase, Alkaline Phosphatase at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Description	Following parameters were analyzed for laboratory examination: Aspartate Aminotransferase (AMT), Creatine Kinase (CK), Alanine Aminotransferase (ALT), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LD), Alkaline Phosphatase (AP).
Time Frame	Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline: AST	22.2 (3.13)	21.2 (1.60)	25.5 (11.38)	19.5 (4.55)
Change at Day 28: AST	-1.2 (8.16)	-1.0 (1.41)	-6.8 (12.26)	-1.3 (3.20)
Change at Day 56: AST	1.3 (3.93)	0.0 (0.89)	-3.7 (10.05)	2.5 (7.79)
Change at Day 84: AST	-3.5 (2.95)	-0.2 (2.48)	-4.3 (11.02)	-0.8 (3.86)
Change at Day 112: AST	0.2 (5.81)	2.0 (1.67)	-5.8 (11.61)	-2.2 (2.77)
Change at Day 140: AST	-3.3 (4.27)	-0.5 (2.35)	-5.2 (9.58)	-1.0 (4.64)
Change at Day 168: AST	-3.2 (2.64)	-0.3 (3.14)	-6.2 (9.26)	0.6 (3.65)
Change at Day 224/ET: AST	0.3 (4.18)	-0.7 (4.27)	-3.8 (11.34)	1.8 (2.64)
Change at Day 304/ET: AST	-0.5 (1.87)	-3.8 (9.77)	7.5 (10.47)
Baseline: CK	97.2 (40.32)	104.8 (74.79)	80.0 (20.21)	67.5 (26.91)
Change at Day 28: CK	-26.3 (26.07)	0.7 (15.06)	-7.3 (24.10)	9.2 (18.69)
Change at Day 56: CK	-0.5 (79.89)	-4.2 (12.48)	12.0 (11.45)	8.7 (15.60)
Change at Day 84: CK	-15.3 (12.60)	1.0 (18.22)	7.5 (26.77)	3.2 (14.20)
Change at Day 112: CK	-32.5 (34.16)	7.5 (18.73)	2.8 (13.10)	-2.0 (19.79)
Change at Day 140: CK	-16.7 (28.79)	7.7 (19.71)	0.5 (29.92)	53.0 (106.50)
Change at Day 168: CK	-29.3 (24.47)	16.3 (45.35)	21.7 (59.27)	8.8 (16.16)
Change at Day 224/ET: CK	15.0 (43.26)	19.0 (29.14)	77.8 (148.91)	7.5 (9.79)
Change at Day 304/ET: CK	61.8 (134.00)	19.0 (31.69)	9.5 (8.58)
Baseline: ALT	17.0 (4.00)	19.5 (1.64)	24.3 (14.14)	17.2 (5.27)
Change at Day 28: ALT	-0.3 (5.13)	0.3 (2.66)	-11.3 (14.24)	-0.2 (0.98)
Change at Day 56: ALT	1.8 (3.54)	0.8 (1.60)	-6.2 (13.70)	3.3 (11.24)
Change at Day 84: ALT	-1.8 (4.07)	-1.2 (2.40)	-6.8 (14.13)	-2.5 (3.32)
Change at Day 112: ALT	8.2 (25.13)	2.2 (2.48)	-7.2 (14.50)	-2.2 (3.96)
Change at Day 140: ALT	-3.0 (4.15)	-1.8 (3.49)	-6.5 (10.54)	-1.0 (4.06)
Change at Day 168: ALT	-2.0 (4.52)	-1.2 (3.54)	-8.7 (13.81)	0.8 (4.55)
Change at Day 224/ET: ALT	1.0 (3.69)	-1.0 (3.46)	-6.7 (13.28)	0.3 (3.44)
Change at Day 304/ET: ALT	0.3 (1.97)	-6.8 (12.80)	13.8 (25.33)
Baseline: GGT	22.0 (6.78)	21.5 (8.29)	17.3 (7.37)	20.0 (10.32)
Change at Day 28: GGT	-2.7 (2.58)	-0.3 (3.93)	-1.8 (2.06)	-0.7 (1.21)
Change at Day 56: GGT	-2.3 (3.39)	-1.3 (3.27)	0.5 (2.59)	-0.8 (1.17)
Change at Day 84: GGT	-2.0 (4.05)	-0.7 (2.34)	-0.7 (4.80)	-2.0 (4.12)
Change at Day 112: GGT	-2.2 (6.88)	-0.8 (4.75)	-1.2 (2.48)	-1.0 (3.39)
Change at Day 140: GGT	-4.5 (5.01)	-2.2 (4.71)	-0.2 (2.04)	0.0 (1.41)
Change at Day 168: GGT	-5.0 (4.52)	-2.3 (5.01)	-1.3 (2.73)	0.8 (1.92)
Change at Day 224/ET: GGT	-3.3 (3.33)	-1.5 (3.39)	0.2 (2.56)	1.3 (3.98)
Change at Day 304/ET: GGT	-2.3 (4.32)	0.5 (1.97)	31.5 (61.07)
Baseline: LD	174.5 (13.40)	174.7 (25.11)	166.7 (19.65)	172.0 (20.03)
Change at Day 28: LD	-15.7 (13.06)	-14.5 (9.89)	-8.0 (15.47)	-4.3 (20.26)
Change at Day 56: LD	-3.0 (30.42)	-10.0 (7.69)	-1.2 (13.51)	1.2 (8.53)
Change at Day 84: LD	-11.3 (9.40)	-3.5 (17.93)	-1.7 (13.69)	3.3 (25.53)
Change at Day 112: LD	-18.0 (6.90)	0.0 (17.42)	-0.8 (12.72)	-6.0 (15.87)
Change at Day 140: LD	-17.3 (9.65)	-14.0 (21.95)	-1.0 (15.48)	-1.2 (16.57)
Change at Day 168: LD	-7.5 (18.56)	-6.5 (17.56)	-2.8 (13.51)	0.2 (18.35)
Change at Day 224/ET: LD	5.7 (27.16)	-6.0 (13.11)	4.8 (18.63)	-4.0 (18.61)
Change at Day 304/ET: LD	-5.2 (15.56)	7.2 (19.22)	-6.5 (38.66)
Baseline: AP	63.5 (20.34)	72.5 (22.65)	59.3 (12.72)	69.7 (9.73)
Change at Day 28: AP	-1.3 (3.72)	-4.0 (4.43)	-6.8 (2.50)	-1.7 (3.78)
Change at Day 56: AP	-2.3 (6.56)	-4.7 (3.98)	-5.3 (9.87)	-0.8 (3.31)
Change at Day 84: AP	-2.3 (8.62)	-0.8 (6.31)	-7.7 (9.67)	0.2 (5.89)
Change at Day 112: AP	-1.7 (7.17)	-0.5 (10.84)	-6.5 (8.24)	5.8 (5.12)
Change at Day 140: AP	-1.0 (12.12)	-6.5 (10.80)	-6.5 (8.98)	1.4 (4.51)
Change at Day 168: AP	-1.3 (8.36)	-4.2 (10.61)	-5.8 (11.25)	3.4 (5.55)
Change at Day 224/ET: AP	3.3 (9.95)	-6.0 (9.32)	-6.2 (10.94)	8.8 (9.45)
Change at Day 304/ET: AP	-5.8 (14.80)	-3.3 (11.52)	9.3 (18.71)

32. Secondary Outcome

Title	Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET
Time Frame	Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET

Outcome Measure Data

Analysis Population Description

All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here "Number Analyzed" signifies number of participants evaluated for given time point.

Arm/Group Title	RN6G 5 mg/kg	RN6G 10 mg/kg	RN6G 15 mg/kg	Placebo
Arm/Group Description	RN6G (PF-04382923) 5 milligram/kilogram (mg/kg) of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5.	Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5.
Measure Participants	6	6	6	6
Baseline: Sodium	140.0 (1.26)	137.8 (5.88)	140.0 (1.79)	141.7 (2.07)
Change at Day 28: Sodium	-2.3 (3.27)	-0.3 (4.46)	0.3 (0.96)	-1.8 (3.43)
Change at Day 56: Sodium	-0.3 (2.80)	0.5 (4.97)	0.5 (2.17)	0.0 (2.97)
Change at Day 84: Sodium	-0.7 (3.01)	1.3 (3.01)	0.7 (3.33)	1.2 (2.28)
Change at Day 112: Sodium	-0.7 (3.20)	1.0 (3.41)	0.7 (3.39)	1.6 (3.13)
Change at Day 140: Sodium	0.0 (1.67)	0.0 (1.41)	2.0 (2.45)	1.0 (2.55)
Change at Day 168: Sodium	-1.3 (4.08)	0.5 (4.14)	3.5 (1.38)	0.6 (3.05)
Change at Day 224/ET: Sodium	0.2 (2.40)	1.5 (3.83)	2.5 (2.07)	-0.2 (2.48)
Change at Day 304/ET: Sodium	1.5 (3.15)	2.2 (2.32)	1.0 (2.45)
Baseline: Potassium	4.52 (0.204)	4.40 (0.200)	4.22 (0.475)	4.42 (0.354)
Change at Day 28: Potassium	-0.18 (0.183)	-0.07 (0.266)	-0.08 (0.15)	-0.23 (0.427)
Change at Day 56: Potassium	-0.18 (0.223)	-0.07 (0.266)	-0.12 (0.504)	-0.13 (0.367)
Change at Day 84: Potassium	-0.28 (0.248)	0.08 (0.248)	0.10 (0.438)	-0.16 (0.439)
Change at Day 112: Potassium	-0.10 (0.322)	0.10 (0.303)	0.00 (0.490)	0.02 (0.593)
Change at Day 140: Potassium	-0.20 (0.253)	0.08 (0.160)	-0.03 (0.535)	0.02 (0.536)
Change at Day 168: Potassium	0.03 (0.121)	-0.05 (0.468)	0.08 (0.467)	-0.04 (0.586)
Change at Day 224/ET: Potassium	-0.20 (0.276)	0.15 (0.394)	0.20 (0.329) <