| Primary | Number of Participants With Toxicity or Intolerable Dose Criteria | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo. | Posted | | Number | | Participants | | Baseline up to Day 304/End of Treatment (ET) | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5. |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | 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). | Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo. | Posted | | Count of Participants | | Participants | | Baseline up to Day 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo. | Posted | | Count of Participants | | Participants | | Baseline up to Day 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Primary | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | 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). | Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo. | Posted | | Count of Participants | | Participants | | Baseline up to Day 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Primary | Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo. | Posted | | Count of Participants | | Participants | | Baseline up to Day 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | |
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| Primary | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity | 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). | Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo. | Posted | | Count of Participants | | Participants | | Baseline up to Day 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | |
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| Primary | Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study drug or placebo. | Posted | | Count of Participants | | Participants | | Baseline up to Day 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg |
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| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) | Area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau = 672 hours. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram*hour per milliliter (mcg*h/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (mcg/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (mcg/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) | Css is the concentration of the drug at the state when the amount of drug administered is equal to the amount of drug eliminated. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (mcg/mL) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) | | 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. | Posted | | Median | Full Range | Hour | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milliliter per kilogram (mL/kg) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Mean Residence Time (MRT) of RN6G (PF-04382923) | The mean total time drug resides in the body. | 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. | Posted | | Mean | Standard Deviation | Hour | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Systemic Clearance (CL) of RN6G (PF-04382923) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milliliter per hour per kilogram | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 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. | Posted | | Mean | Standard Deviation | Hour | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | 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 | Amyloid (A) Beta (1-X) is a primary activator of complement in Alzheimer's disease (AD). | 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. | Posted | | Mean | Standard Deviation | Picogram per milliliter (pg/ml) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
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| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | Percent change | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
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| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | Picogram per milliliter (pg/ml) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
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| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | percent change | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
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| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | picogram per milliliter (pg/ml) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
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| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | percent change | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
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| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | |
|
| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | Beats per minute | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
|
| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | Degree Celsius | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
|
| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | Kilogram | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
|
| Secondary | Change From Baseline Electrocardiogram (ECG) 12-lead at Day 1, 28, 56, 84, 112, 140, 168, 224, 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. | 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. | Posted | | Mean | Standard Deviation | Millisecond | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
|
| Secondary | Change From Baseline in Heart Rate at Day 1, 28, 56, 84, 112, 140, 168, 224, 304/ET | | 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. | Posted | | Mean | Standard Deviation | Beats per minute | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | |
|
| Secondary | 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 | 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) | 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. | Posted | | Mean | Standard Deviation | Milligram per deciliter (MG/DL) | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 |
|
| Secondary | Change From Baseline in Laboratory Assessments: Protein, Albumin, Hemoglobin at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | 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. | Posted | | Mean | Standard Deviation | Gram per deciliter (g/dL) | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5. |
|
| Secondary | 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 | 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). | 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. | Posted | | Mean | Standard Deviation | international units per liter (IU/L) | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
|
| Secondary | Change From Baseline in Laboratory Assessments: Sodium, Potassium, Chloride, Bicarbonate, Magnesium at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | 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. | Posted | | Mean | Standard Deviation | Milliequivalent per liter (mEq/L) | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | |
|
| Secondary | Change From Baseline in Laboratory Assessments: Hematocrit at 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). | 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. | Posted | | Mean | Standard Deviation | Percentage of RBCs to total blood volume | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
|
| Secondary | Change From Baseline in Laboratory Assessments: Red Blood Cells (RBCs) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | 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. | Posted | | Mean | Standard Deviation | 10^6 cells/microliter | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5. |
|
| Secondary | 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 | | 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. | Posted | | Mean | Standard Deviation | 10^3 cells/microliter | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo |
|
| Secondary | Change From Baseline in Laboratory Assessments: Prothrombin Time (PT), Partial Thromboplastin Time at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | Following hematology parameters were analyzed for laboratory examination: Prothrombin Time (PT), Partial Thromboplastin Time. | 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. | Posted | | Mean | Standard Deviation | Second | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
|
| Secondary | Change From Baseline in Laboratory Assessments: Urine Specific Gravity at 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. | 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. | Posted | | Mean | Standard Deviation | ratio | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo |
|
| Secondary | Change From Baseline in Laboratory Assessments: Urine pH at 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 |
|
| Secondary | Change From Baseline in Laboratory Assessments: Beta Interleukin-1, Interleukin-6, Alpha Tumor Necrosis Factor, Interferon (Gamma) at Day 28, 56, 84, 112, 140 | | 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. | Posted | | Mean | Standard Deviation | Picogram per milliliter (pg/ml) | | Baseline, Day 28, 56, 84, 112, 140 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | |
|
| Secondary | Change From Baseline in Laboratory Assessments: Component of Complement (C3A, C5B-9) at Day 28, 56, 84, 112, 140 | | 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. | Posted | | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | | Baseline, Day 28, 56, 84, 112, 140 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5. |
|
| Secondary | Change From Baseline in Laboratory Assessments: Cluster of Differentiation 4 (C4D) at Day 28, 56, 84, 112, 140 | | All randomized participants who met the inclusion criteria and received any amount of study drug were included. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluated for given time point. | Posted | | Mean | Standard Deviation | Microgram per milliliter (mcg/mL) | | Baseline, Day 28, 56, 84, 112, 140 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo |
|
| Secondary | Change From Baseline in Prothrombin Time (PT) International Normalized Ratio (INR) at Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | 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. | Posted | | Mean | Standard Deviation | Ratio | | Baseline, Day 28, 56, 84, 112, 140, 168, 224, 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG003 | Placebo | Placebo intravenous infusion over 60 minutes, every 4 weeks, until unacceptable toxicity, up to Month 5. |
|
| Secondary | Change From Electrocardiogram (ECG): QTcF Interval (Fridericia's Correction) at Day 1, 28, 56, 84, 112, 140, 168, 224, 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. | 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. | Posted | | Mean | Standard Deviation | Millisecond (msec) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
|
| Primary | Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) | 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. | Analysis population included all randomized participants who met the inclusion criteria and received any amount of study drug. Here "Number Analyzed" signifies number of participants evaluated for specified category. Data for Nab was not estimable as no participant was eligible for neutralizing antibody assessment, as there were no positive ADA samples. | Posted | | Count of Participants | | Participants | | Baseline up to Day 304/ET | | | | ID | Title | Description |
|---|
| OG000 | RN6G 5 mg/kg | 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. | | OG001 | RN6G 10 mg/kg | RN6G (PF-04382923) 10 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. | | OG002 | RN6G 15 mg/kg | RN6G (PF-04382923) 15 mg/kg of body weight, intravenous infusion over 60 minutes every 4 weeks until unacceptable toxicity, up to Month 5. |
|