Trial Outcomes & Findings for A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease (NCT NCT00945672)
NCT ID: NCT00945672
Last Updated: 2024-04-19
Results Overview
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Day 1 up to 6 months after last dose of study medication (up to 18 months)
Results posted on
2024-04-19
Participant Flow
Participant milestones
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
12
|
6
|
|
Overall Study
COMPLETED
|
12
|
6
|
12
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
71.3 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
69.8 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
65.8 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 7.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 6 months after last dose of study medication (up to 18 months)Population: Safety analysis set included all randomized participants who received at least 1 infusion of study medication.
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
9 Participants
|
5 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 18Population: Safety analysis set included all randomized participants who received at least 1 infusion of study medication.
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Micro Hemorrhage
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Other
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 18Population: Safety analysis set included all randomized participants who received at least 1 infusion of study medication.
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 13Population: Per Protocol (PP) analysis set included all participants who had received the study drug infusions consistent with the protocol specified procedures, had successful PET scans at Month 13, and had no major protocol deviations. Only participants in cohort M were planned to be analyzed for this outcome measure.
Quantitative amyloid imaging was performed using PET technique using \[11C\] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Temporal Medial
|
-0.009 Standard update value ratio
Standard Deviation 0.0960
|
-0.025 Standard update value ratio
Standard Deviation 0.2255
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Posterior Cingulum
|
-0.065 Standard update value ratio
Standard Deviation 0.2770
|
-0.103 Standard update value ratio
Standard Deviation 0.3539
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Pons
|
-0.026 Standard update value ratio
Standard Deviation 0.2034
|
-0.013 Standard update value ratio
Standard Deviation 0.2181
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Subcortical White Matter
|
-0.083 Standard update value ratio
Standard Deviation 0.2047
|
-0.024 Standard update value ratio
Standard Deviation 0.2781
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Frontal Cortex
|
2.781 Standard update value ratio
Standard Deviation 0.6769
|
2.835 Standard update value ratio
Standard Deviation 0.3775
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Parietal Cortex
|
2.480 Standard update value ratio
Standard Deviation 0.5175
|
2.647 Standard update value ratio
Standard Deviation 0.4020
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Lateral Temporal Cortex
|
2.492 Standard update value ratio
Standard Deviation 0.4945
|
2.626 Standard update value ratio
Standard Deviation 0.3327
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Occipital Cortex
|
2.085 Standard update value ratio
Standard Deviation 0.4064
|
1.994 Standard update value ratio
Standard Deviation 0.2066
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Cerebellum
|
1.000 Standard update value ratio
Standard Deviation 0.0000
|
1.000 Standard update value ratio
Standard Deviation 0.0000
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Striatum
|
2.325 Standard update value ratio
Standard Deviation 0.4351
|
2.440 Standard update value ratio
Standard Deviation 0.3468
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Anterior Cingulum
|
2.723 Standard update value ratio
Standard Deviation 0.6085
|
2.845 Standard update value ratio
Standard Deviation 0.3109
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Temporal Medial
|
1.557 Standard update value ratio
Standard Deviation 0.1693
|
1.615 Standard update value ratio
Standard Deviation 0.1334
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Posterior Cingulum
|
2.866 Standard update value ratio
Standard Deviation 0.5547
|
2.927 Standard update value ratio
Standard Deviation 0.3624
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Pons
|
2.042 Standard update value ratio
Standard Deviation 0.3195
|
2.091 Standard update value ratio
Standard Deviation 0.3871
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Baseline: Subcortical White Matter
|
2.315 Standard update value ratio
Standard Deviation 0.3442
|
2.407 Standard update value ratio
Standard Deviation 0.3180
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Frontal Cortex
|
-0.092 Standard update value ratio
Standard Deviation 0.3081
|
-0.096 Standard update value ratio
Standard Deviation 0.3243
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Parietal Cortex
|
-0.030 Standard update value ratio
Standard Deviation 0.2039
|
-0.113 Standard update value ratio
Standard Deviation 0.3309
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Lateral Temporal Cortex
|
-0.056 Standard update value ratio
Standard Deviation 0.2485
|
-0.094 Standard update value ratio
Standard Deviation 0.2956
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Occipital Cortex
|
-0.066 Standard update value ratio
Standard Deviation 0.2027
|
0.047 Standard update value ratio
Standard Deviation 0.2409
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Cerebellum
|
0.000 Standard update value ratio
Standard Deviation 0.0000
|
0.000 Standard update value ratio
Standard Deviation 0.0000
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Striatum
|
-0.047 Standard update value ratio
Standard Deviation 0.1602
|
-0.091 Standard update value ratio
Standard Deviation 0.2568
|
—
|
—
|
|
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M
Change at Month 13: Anterior Cingulum
|
-0.103 Standard update value ratio
Standard Deviation 0.2397
|
-0.068 Standard update value ratio
Standard Deviation 0.3245
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour on Day 0 (Day prior to dosing)Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=12 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
|
0.00 Nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
0.00 Nanogram per milliliter (ng/mL)
Standard Deviation 0.00
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 1Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=11 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
|
0.00 ng/mL
Standard Deviation 0.00
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 1Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=12 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1
|
191080.73 ng/mL
Standard Deviation 27645.17
|
190826.33 ng/mL
Standard Deviation 64016.37
|
—
|
—
|
PRIMARY outcome
Timeframe: 216 hours post dose on Day 1 (samples taken on Day 10)Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M
CSF
|
167.25 ng/mL
Standard Deviation 52.68
|
—
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M
Plasma
|
77466.25 ng/mL
Standard Deviation 11446.87
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 456 hours post dose on Day 1 (samples taken on Day 20)Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M
CSF
|
192.50 ng/mL
Standard Deviation 90.50
|
—
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M
Plasma
|
68219.25 ng/mL
Standard Deviation 18837.66
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 30Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for the specified rows. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M
CSF
|
185.33 ng/mL
Standard Deviation 86.53
|
—
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M
Plasma
|
46321.00 ng/mL
Standard Deviation 5902.85
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 30Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M
|
196752.82 ng/mL
Standard Deviation 25216.35
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 936 hours post dose on Day 1 (samples taken on Day 40)Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q
CSF
|
121.73 ng/mL
Standard Deviation 35.25
|
—
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q
Plasma
|
34794.50 ng/mL
Standard Deviation 4381.87
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1176 hours post dose on Day 1 (samples taken on Day 50)Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q
CSF
|
107.03 ng/mL
Standard Deviation 44.93
|
—
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q
Plasma
|
40038.50 ng/mL
Standard Deviation 11862.03
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1416 hours post-dose on Day 1 (samples taken on Day 60)Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for the specified rows. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q
CSF
|
84.50 ng/mL
Standard Deviation 25.51
|
—
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q
Plasma
|
22917.00 ng/mL
Standard Deviation 4432.31
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 60Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M
|
62261.92 ng/mL
Standard Deviation 13196.38
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 60Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=10 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M
|
199861.90 ng/mL
Standard Deviation 33651.83
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 90Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for specified row for each treatment arm, respectively. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=12 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90
CSF
|
61.15 ng/mL
Standard Deviation 11.76
|
—
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90
Plasma
|
16094.08 ng/mL
Standard Deviation 4932.12
|
68110.83 ng/mL
Standard Deviation 12594.63
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 90Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=10 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90
|
218031.73 ng/mL
Standard Deviation 30864.41
|
212299.30 ng/mL
Standard Deviation 20405.36
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 120Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M
|
73285.25 ng/mL
Standard Deviation 20795.73
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 120Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=10 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M
|
227156.80 ng/mL
Standard Deviation 23587.30
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 150Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M
|
76083.50 ng/mL
Standard Deviation 19076.47
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 150Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M
|
222737.91 ng/mL
Standard Deviation 28714.06
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 180Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for specified rows for each treatment arm, respectively. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=12 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180
CSF
|
89.20 ng/mL
Standard Deviation 26.12
|
324.82 ng/mL
Standard Deviation 119.92
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180
Plasma
|
23708.42 ng/mL
Standard Deviation 5039.46
|
76593.58 ng/mL
Standard Deviation 14452.02
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 180Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=10 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180
|
226842.91 ng/mL
Standard Deviation 22478.66
|
210905.00 ng/mL
Standard Deviation 26474.96
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 210Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M
|
77315.33 ng/mL
Standard Deviation 14237.02
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 210Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M
|
223667.00 ng/mL
Standard Deviation 28942.32
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 240Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M
|
82563.83 ng/mL
Standard Deviation 21690.43
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 240Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M
|
223715.91 ng/mL
Standard Deviation 29306.75
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 270Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=12 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270
|
22140.00 ng/mL
Standard Deviation 8996.92
|
69838.25 ng/mL
Standard Deviation 16735.16
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 270Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=7 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=11 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270
|
219643.86 ng/mL
Standard Deviation 21122.06
|
218116.27 ng/mL
Standard Deviation 20328.81
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 300Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M
|
71822.18 ng/mL
Standard Deviation 16913.55
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 300Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=10 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M
|
227333.20 ng/mL
Standard Deviation 30922.55
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 330Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M
|
71668.67 ng/mL
Standard Deviation 19448.75
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 330Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=9 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M
|
216841.22 ng/mL
Standard Deviation 38575.76
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 360Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=12 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360
CSF
|
68.71 ng/mL
Standard Deviation 27.52
|
240.19 ng/mL
Standard Deviation 93.38
|
—
|
—
|
|
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360
Plasma
|
20347.00 ng/mL
Standard Deviation 8570.57
|
70238.33 ng/mL
Standard Deviation 23030.37
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 hours post-infusion start on Day 360Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=11 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=11 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360
|
222927.73 ng/mL
Standard Deviation 29419.72
|
213278.09 ng/mL
Standard Deviation 31361.98
|
—
|
—
|
PRIMARY outcome
Timeframe: 720 hours post-dose on Day 360 (samples taken on Day 390)Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=9 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q
|
59095.22 ng/mL
Standard Deviation 9470.32
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 390Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M
|
74846.08 ng/mL
Standard Deviation 25913.06
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hours (pre-dose) on Day 540Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q
|
6245.83 ng/mL
Standard Deviation 3567.48
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 540Population: PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure.
Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M
|
5987.08 ng/mL
Standard Deviation 3571.64
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour on Day 0 (Day prior to dosing)Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 infusion of study medication.
A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42).
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0
A-beta 1-x
|
31150.00 Picogram per milliliter (pg/mL)
Standard Deviation 9063.66
|
28533.33 Picogram per milliliter (pg/mL)
Standard Deviation 5269.41
|
30497.50 Picogram per milliliter (pg/mL)
Standard Deviation 16885.00
|
28500.00 Picogram per milliliter (pg/mL)
Standard Deviation 8696.44
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0
A-beta 1-40
|
15794.17 Picogram per milliliter (pg/mL)
Standard Deviation 7569.38
|
13296.67 Picogram per milliliter (pg/mL)
Standard Deviation 2428.35
|
11688.33 Picogram per milliliter (pg/mL)
Standard Deviation 3813.40
|
12215.00 Picogram per milliliter (pg/mL)
Standard Deviation 2674.13
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0
A-beta 1-42
|
1003.75 Picogram per milliliter (pg/mL)
Standard Deviation 358.30
|
882.00 Picogram per milliliter (pg/mL)
Standard Deviation 185.95
|
758.67 Picogram per milliliter (pg/mL)
Standard Deviation 204.65
|
870.00 Picogram per milliliter (pg/mL)
Standard Deviation 270.25
|
PRIMARY outcome
Timeframe: 216 hours post-dose on Day 1Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=1 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M
A-beta 1-x
|
22.32 pg/mL
Standard Deviation 17.55
|
-21.21 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M
A-beta 1-40
|
9.24 pg/mL
Standard Deviation 44.06
|
1.43 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M
A-beta 1-42
|
-0.46 pg/mL
Standard Deviation 14.59
|
-3.78 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
PRIMARY outcome
Timeframe: 456 hours post-dose on Day 1Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=1 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M
A-beta 1-x
|
-2.38 pg/mL
Standard Deviation 14.01
|
-5.95 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M
A-beta 1-40
|
4.23 pg/mL
Standard Deviation 25.16
|
-8.75 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M
A-beta 1-42
|
8.14 pg/mL
Standard Deviation 31.37
|
-24.57 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 30Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=2 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M
A-beta 1-x
|
0.80 pg/mL
Standard Deviation 31.57
|
-0.79 pg/mL
Standard Deviation 30.68
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M
A-beta 1-40
|
43.33 pg/mL
Standard Deviation 20.67
|
-17.07 pg/mL
Standard Deviation 19.05
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M
A-beta 1-42
|
14.15 pg/mL
Standard Deviation 17.45
|
-13.98 pg/mL
Standard Deviation 12.48
|
—
|
—
|
PRIMARY outcome
Timeframe: 936 hours post-dose on Day 1 (Samples taken on Day 40)Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=2 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q
A-beta 1-x
|
16.78 pg/mL
Standard Deviation 9.69
|
5.05 pg/mL
Standard Deviation 3.71
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q
A-beta 1-40
|
26.77 pg/mL
Standard Deviation 16.01
|
160.62 pg/mL
Standard Deviation 51.13
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q
A-beta 1-42
|
17.30 pg/mL
Standard Deviation 14.03
|
-7.40 pg/mL
Standard Deviation 13.74
|
—
|
—
|
PRIMARY outcome
Timeframe: 1176 hours post-dose on Day 1 (Samples taken on Day 50)Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=2 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q
A-beta 1-x
|
12.35 pg/mL
Standard Deviation 11.45
|
-1.60 pg/mL
Standard Deviation 9.02
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q
A-beta 1-40
|
-17.98 pg/mL
Standard Deviation 37.02
|
-6.67 pg/mL
Standard Deviation 9.43
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q
A-beta 1-42
|
2.32 pg/mL
Standard Deviation 16.51
|
-3.36 pg/mL
Standard Deviation 18.68
|
—
|
—
|
PRIMARY outcome
Timeframe: 1416 hours post-dose on Day 1 (Samples taken on Day 60)Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=2 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q
A-beta 1-x
|
9.62 pg/mL
Standard Deviation 6.51
|
0.04 pg/mL
Standard Deviation 1.33
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q
A-beta 1-40
|
27.85 pg/mL
Standard Deviation 35.55
|
-5.61 pg/mL
Standard Deviation 0.44
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q
A-beta 1-42
|
9.52 pg/mL
Standard Deviation 14.31
|
-12.08 pg/mL
Standard Deviation 2.95
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 90Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=4 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=1 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q
A-beta 1-x
|
-0.51 pg/mL
Standard Deviation 8.96
|
-15.57 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q
A-beta 1-40
|
27.67 pg/mL
Standard Deviation 40.65
|
-23.23 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q
A-beta 1-42
|
-15.62 pg/mL
Standard Deviation 18.01
|
-38.65 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 180Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for specified amyloid beta for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=8 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=4 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=5 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180
A-beta 1-x
|
-37.94 pg/mL
Standard Deviation 9.81
|
-44.49 pg/mL
Standard Deviation 10.99
|
13.91 pg/mL
Standard Deviation 21.25
|
-0.57 pg/mL
Standard Deviation 23.16
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180
A-beta 1-40
|
-60.93 pg/mL
Standard Deviation 13.99
|
-60.42 pg/mL
Standard Deviation 7.98
|
179.14 pg/mL
Standard Deviation 121.44
|
147.17 pg/mL
Standard Deviation 126.47
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180
A-beta 1-42
|
18.57 pg/mL
Standard Deviation 19.99
|
-4.18 pg/mL
Standard Deviation 22.66
|
75.58 pg/mL
Standard Deviation 45.47
|
-15.77 pg/mL
Standard Deviation 34.09
|
PRIMARY outcome
Timeframe: 0 hour (pre-dose) on Day 360Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for specified amyloid beta for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=5 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=5 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360
A-beta 1-x
|
-16.70 pg/mL
Standard Deviation 22.23
|
-30.01 pg/mL
Standard Deviation 11.85
|
-27.69 pg/mL
Standard Deviation 28.11
|
-42.16 pg/mL
Standard Deviation 17.77
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360
A-beta 1-40
|
98.33 pg/mL
Standard Deviation 133.77
|
35.60 pg/mL
Standard Deviation 122.29
|
3.07 pg/mL
Standard Deviation 69.15
|
56.66 pg/mL
Standard Deviation 90.93
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360
A-beta 1-42
|
-26.70 pg/mL
Standard Deviation 40.32
|
-40.24 pg/mL
Standard Deviation 14.77
|
49.15 pg/mL
Standard Deviation 54.18
|
-27.46 pg/mL
Standard Deviation 11.27
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6, 9, 13, 18Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). The total score was calculated as the sum of the scores for the 11 items. ADAS-cog total score ranges from 0 (no impairment) to 70 (maximum impairment). Higher total and individual item scores indicate greater cognitive impairment.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18
Baseline
|
18.6 units on a scale
Standard Deviation 8.71
|
23.5 units on a scale
Standard Deviation 12.56
|
18.2 units on a scale
Standard Deviation 6.57
|
20.1 units on a scale
Standard Deviation 9.79
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18
Change at Month 3
|
0.5 units on a scale
Standard Deviation 8.31
|
1.9 units on a scale
Standard Deviation 5.43
|
-2.6 units on a scale
Standard Deviation 5.33
|
-2.4 units on a scale
Standard Deviation 3.72
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18
Change at Month 6
|
2.3 units on a scale
Standard Deviation 5.96
|
2.3 units on a scale
Standard Deviation 6.11
|
-0.6 units on a scale
Standard Deviation 7.32
|
-4.3 units on a scale
Standard Deviation 3.58
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18
Change at Month 9
|
2.4 units on a scale
Standard Deviation 9.29
|
2.8 units on a scale
Standard Deviation 11.00
|
1.6 units on a scale
Standard Deviation 6.11
|
-0.5 units on a scale
Standard Deviation 6.34
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18
Change at Month 13
|
0.8 units on a scale
Standard Deviation 6.27
|
0.9 units on a scale
Standard Deviation 6.42
|
3.8 units on a scale
Standard Deviation 8.04
|
-2.0 units on a scale
Standard Deviation 2.91
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18
Change at Month 18
|
5.4 units on a scale
Standard Deviation 8.43
|
-3.7 units on a scale
Standard Deviation 0.72
|
5.9 units on a scale
Standard Deviation 10.47
|
5.7 units on a scale
Standard Deviation 5.51
|
SECONDARY outcome
Timeframe: Baseline, Month 6, 13, 18Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
DAD is a functional assessment based on interview with the caregiver of participants. It consists of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item scored as yes = 1, no = 0 and not applicable= N/A. A total score is obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A are not considered for the total score. DAD total score range from 0 (more dysfunction) to 100 (better function), with higher scores indicating better functioning.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18
Baseline
|
90.2 units on a scale
Standard Deviation 12.58
|
85.6 units on a scale
Standard Deviation 15.35
|
75.4 units on a scale
Standard Deviation 17.85
|
87.3 units on a scale
Standard Deviation 19.09
|
|
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18
Change at Month 6
|
-2.1 units on a scale
Standard Deviation 4.51
|
-3.4 units on a scale
Standard Deviation 9.19
|
-1.2 units on a scale
Standard Deviation 13.06
|
-1.0 units on a scale
Standard Deviation 8.33
|
|
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18
Change at Month 13
|
-9.5 units on a scale
Standard Deviation 16.63
|
-20.1 units on a scale
Standard Deviation 22.81
|
-8.5 units on a scale
Standard Deviation 23.78
|
-10.4 units on a scale
Standard Deviation 19.10
|
|
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18
Change at Month 18
|
-19.9 units on a scale
Standard Deviation 21.43
|
-28.0 units on a scale
Standard Deviation 12.04
|
-17.1 units on a scale
Standard Deviation 24.18
|
-14.7 units on a scale
Standard Deviation 14.54
|
SECONDARY outcome
Timeframe: Baseline, Month 13Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total MMSE score ranged from 0 (worst cognitive state) to 30 (best cognitive state), where higher score indicates better cognitive state.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13
Baseline
|
21.8 units on a scale
Standard Deviation 3.81
|
20.3 units on a scale
Standard Deviation 3.27
|
20.7 units on a scale
Standard Deviation 3.68
|
21.7 units on a scale
Standard Deviation 4.84
|
|
Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13
Change at Month 13
|
-1.5 units on a scale
Standard Deviation 2.50
|
-3.3 units on a scale
Standard Deviation 6.68
|
-1.3 units on a scale
Standard Deviation 3.57
|
-2.8 units on a scale
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Cohort M&Q: 0 hour(hr) & 0.25 hrs post dose (pd) on Day (D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936,1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D 60, 0 hr & 0.25 hrs pd on D 30,120,150,210,240,300,330Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 1
|
128.92 pg/mL
Standard Deviation 129.49
|
136.00 pg/mL
Standard Deviation 107.16
|
190.67 pg/mL
Standard Deviation 133.79
|
167.17 pg/mL
Standard Deviation 169.34
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 1
|
454.50 pg/mL
Standard Deviation 214.42
|
191.17 pg/mL
Standard Deviation 97.01
|
551.33 pg/mL
Standard Deviation 344.39
|
196.00 pg/mL
Standard Deviation 152.32
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 10
|
—
|
—
|
86025.00 pg/mL
Standard Deviation 17717.48
|
171.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 20
|
—
|
—
|
97633.33 pg/mL
Standard Deviation 16223.54
|
268.50 pg/mL
Standard Deviation 55.86
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 30
|
—
|
—
|
112571.43 pg/mL
Standard Deviation 20332.79
|
273.25 pg/mL
Standard Deviation 125.07
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 30
|
—
|
—
|
90900.00 pg/mL
Standard Deviation 21793.12
|
288.25 pg/mL
Standard Deviation 124.20
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 40
|
97225.00 pg/mL
Standard Deviation 18871.56
|
266.00 pg/mL
Standard Deviation 29.70
|
—
|
—
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 50
|
104833.33 pg/mL
Standard Deviation 15671.10
|
299.00 pg/mL
Standard Deviation 50.91
|
—
|
—
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 60
|
112100.00 pg/mL
Standard Deviation 14255.88
|
455.50 pg/mL
Standard Deviation 78.49
|
114650.00 pg/mL
Standard Deviation 15162.55
|
234.33 pg/mL
Standard Deviation 33.98
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 60
|
—
|
—
|
115600.00 pg/mL
Standard Deviation 8763.56
|
226.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 90
|
69650.00 pg/mL
Standard Deviation 19280.49
|
327.25 pg/mL
Standard Deviation 162.98
|
107400.00 pg/mL
Standard Deviation 14208.45
|
340.75 pg/mL
Standard Deviation 183.38
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 120
|
—
|
—
|
114440.00 pg/mL
Standard Deviation 20378.13
|
373.50 pg/mL
Standard Deviation 181.21
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 120
|
—
|
—
|
99425.00 pg/mL
Standard Deviation 18753.38
|
249.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 150
|
—
|
—
|
112920.00 pg/mL
Standard Deviation 18388.37
|
276.67 pg/mL
Standard Deviation 292.63
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 150
|
—
|
—
|
100266.67 pg/mL
Standard Deviation 28577.87
|
336.33 pg/mL
Standard Deviation 233.34
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 180
|
76533.33 pg/mL
Standard Deviation 11019.23
|
459.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
123333.33 pg/mL
Standard Deviation 14066.51
|
280.33 pg/mL
Standard Deviation 256.41
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 180
|
67000.00 pg/mL
Standard Deviation 12926.20
|
399.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
106500.00 pg/mL
Standard Deviation 20753.31
|
278.00 pg/mL
Standard Deviation 297.64
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 210
|
—
|
—
|
103075.00 pg/mL
Standard Deviation 18902.09
|
570.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 240
|
—
|
—
|
115700.00 pg/mL
Standard Deviation 22991.74
|
334.00 pg/mL
Standard Deviation 430.61
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 240
|
—
|
—
|
101700.00 pg/mL
Standard Deviation 25123.69
|
303.33 pg/mL
Standard Deviation 339.46
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 270
|
72775.00 pg/mL
Standard Deviation 16698.40
|
353.33 pg/mL
Standard Deviation 127.41
|
114500.00 pg/mL
Standard Deviation 10329.57
|
304.67 pg/mL
Standard Deviation 358.70
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 270
|
74000.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
286.67 pg/mL
Standard Deviation 105.04
|
104400.00 pg/mL
Standard Deviation 23665.25
|
142.00 pg/mL
Standard Deviation 200.82
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 300
|
—
|
—
|
112750.00 pg/mL
Standard Deviation 6075.91
|
230.67 pg/mL
Standard Deviation 230.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 300
|
—
|
—
|
101000.00 pg/mL
Standard Deviation 19672.32
|
0.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 330
|
—
|
—
|
119400.00 pg/mL
Standard Deviation 31413.37
|
283.33 pg/mL
Standard Deviation 251.46
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 330
|
—
|
—
|
117000.00 pg/mL
Standard Deviation 19899.75
|
256.33 pg/mL
Standard Deviation 222.01
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 360
|
81483.33 pg/mL
Standard Deviation 11155.34
|
433.33 pg/mL
Standard Deviation 128.94
|
115925.00 pg/mL
Standard Deviation 21198.01
|
267.60 pg/mL
Standard Deviation 188.12
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 360
|
63462.50 pg/mL
Standard Deviation 25395.10
|
—
|
111980.00 pg/mL
Standard Deviation 19276.98
|
247.80 pg/mL
Standard Deviation 226.73
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0.25 Hours Day 90
|
56450.00 pg/mL
Standard Deviation 20203.96
|
349.50 pg/mL
Standard Deviation 180.97
|
94166.67 pg/mL
Standard Deviation 18315.11
|
381.00 pg/mL
Standard Deviation 171.66
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 210
|
—
|
—
|
120400.00 pg/mL
Standard Deviation 34173.09
|
265.33 pg/mL
Standard Deviation 95.93
|
|
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)
0 Hour Day 390
|
—
|
90.00 pg/mL
Standard Deviation 127.28
|
140000.00 pg/mL
Standard Deviation NA
Standard Deviation was not estimable since only 1 participant was evaluated.
|
—
|
SECONDARY outcome
Timeframe: Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390,540; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 1
|
219.44 pg/mL
Standard Deviation 163.52
|
136.60 pg/mL
Standard Deviation 125.87
|
166.20 pg/mL
Standard Deviation 102.44
|
157.20 pg/mL
Standard Deviation 152.25
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 1
|
618.00 pg/mL
Standard Deviation 73.00
|
163.67 pg/mL
Standard Deviation 141.99
|
530.33 pg/mL
Standard Deviation 215.49
|
190.40 pg/mL
Standard Deviation 26.29
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 10
|
—
|
—
|
71233.33 pg/mL
Standard Deviation 2345.92
|
—
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 20
|
—
|
—
|
97725.00 pg/mL
Standard Deviation 29818.05
|
197.50 pg/mL
Standard Deviation 28.99
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 30
|
—
|
—
|
87045.45 pg/mL
Standard Deviation 17785.41
|
216.00 pg/mL
Standard Deviation 39.09
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 30
|
—
|
—
|
93720.00 pg/mL
Standard Deviation 14011.17
|
275.67 pg/mL
Standard Deviation 120.27
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 40
|
65100.00 pg/mL
Standard Deviation 13163.97
|
—
|
—
|
—
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 50
|
105075.00 pg/mL
Standard Deviation 26779.77
|
—
|
—
|
—
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 60
|
106625.00 pg/mL
Standard Deviation 27207.15
|
269.50 pg/mL
Standard Deviation 125.16
|
86383.33 pg/mL
Standard Deviation 22189.79
|
137.67 pg/mL
Standard Deviation 107.77
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 60
|
—
|
—
|
91280.00 pg/mL
Standard Deviation 25493.13
|
197.00 pg/mL
Standard Deviation 133.61
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 90
|
54244.44 pg/mL
Standard Deviation 12650.31
|
225.67 pg/mL
Standard Deviation 61.01
|
92341.67 pg/mL
Standard Deviation 31491.97
|
179.17 pg/mL
Standard Deviation 94.84
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 90
|
50280.00 pg/mL
Standard Deviation 15748.78
|
174.67 pg/mL
Standard Deviation 163.48
|
73400.00 pg/mL
Standard Deviation 29078.63
|
206.67 pg/mL
Standard Deviation 74.95
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 120
|
—
|
—
|
88850.00 pg/mL
Standard Deviation 36003.07
|
243.83 pg/mL
Standard Deviation 54.15
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 120
|
—
|
—
|
78230.00 pg/mL
Standard Deviation 32535.90
|
181.00 pg/mL
Standard Deviation 158.09
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 150
|
—
|
—
|
113788.89 pg/mL
Standard Deviation 36944.09
|
1341.00 pg/mL
Standard Deviation 1913.05
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 150
|
—
|
—
|
107850.00 pg/mL
Standard Deviation 44298.95
|
1422.00 pg/mL
Standard Deviation 1655.19
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 180
|
67566.67 pg/mL
Standard Deviation 20145.35
|
228.17 pg/mL
Standard Deviation 51.76
|
136800.00 pg/mL
Standard Deviation 57309.80
|
623.50 pg/mL
Standard Deviation 505.02
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 180
|
62000.00 pg/mL
Standard Deviation 20374.15
|
211.17 pg/mL
Standard Deviation 107.37
|
154666.67 pg/mL
Standard Deviation 67813.47
|
796.50 pg/mL
Standard Deviation 502.64
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 210
|
—
|
—
|
154142.86 pg/mL
Standard Deviation 68875.32
|
696.50 pg/mL
Standard Deviation 598.92
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 210
|
—
|
—
|
139066.67 pg/mL
Standard Deviation 62146.49
|
663.67 pg/mL
Standard Deviation 413.37
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 240
|
—
|
—
|
156714.29 pg/mL
Standard Deviation 69257.28
|
616.25 pg/mL
Standard Deviation 292.13
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 240
|
—
|
—
|
128000.00 pg/mL
Standard Deviation 43069.71
|
744.50 pg/mL
Standard Deviation 533.68
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 270
|
89062.50 pg/mL
Standard Deviation 36384.45
|
607.17 pg/mL
Standard Deviation 400.20
|
113766.67 pg/mL
Standard Deviation 25223.53
|
473.67 pg/mL
Standard Deviation 61.27
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 270
|
95550.00 pg/mL
Standard Deviation 43062.80
|
735.50 pg/mL
Standard Deviation 481.31
|
150333.33 pg/mL
Standard Deviation 43738.62
|
540.50 pg/mL
Standard Deviation 382.69
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 300
|
—
|
—
|
130000.00 pg/mL
Standard Deviation 30880.41
|
607.50 pg/mL
Standard Deviation 194.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 300
|
—
|
—
|
138780.00 pg/mL
Standard Deviation 72485.46
|
609.67 pg/mL
Standard Deviation 204.23
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 330
|
—
|
—
|
100285.71 pg/mL
Standard Deviation 51435.12
|
1251.40 pg/mL
Standard Deviation 1767.97
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 330
|
—
|
—
|
103666.67 pg/mL
Standard Deviation 81733.31
|
1545.75 pg/mL
Standard Deviation 1545.67
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 360
|
77442.86 pg/mL
Standard Deviation 38989.14
|
1450.83 pg/mL
Standard Deviation 2634.66
|
114612.50 pg/mL
Standard Deviation 17519.82
|
1486.33 pg/mL
Standard Deviation 1673.10
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0.25 Hours Day 360
|
70228.57 pg/mL
Standard Deviation 33633.25
|
3287.50 pg/mL
Standard Deviation 2585.41
|
131000.00 pg/mL
Standard Deviation 33724.37
|
766.00 pg/mL
Standard Deviation 685.10
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 390
|
—
|
673.67 pg/mL
Standard Deviation 629.67
|
—
|
330.00 pg/mL
Standard Deviation 11.31
|
|
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)
0 Hour Day 540
|
—
|
369.00 pg/mL
Standard Deviation 71.73
|
—
|
311.00 pg/mL
Standard Deviation 37.26
|
SECONDARY outcome
Timeframe: Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 1
|
4.62 pg/mL
Standard Deviation 15.99
|
85.23 pg/mL
Standard Deviation 133.09
|
41.05 pg/mL
Standard Deviation 135.84
|
11.82 pg/mL
Standard Deviation 28.94
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 1
|
5.76 pg/mL
Standard Deviation 18.21
|
73.23 pg/mL
Standard Deviation 109.30
|
34.33 pg/mL
Standard Deviation 112.18
|
15.96 pg/mL
Standard Deviation 22.68
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 10
|
—
|
—
|
0.00 pg/mL
Standard Deviation 0.00
|
30.00 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 20
|
—
|
—
|
141.25 pg/mL
Standard Deviation 282.50
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 30
|
—
|
—
|
45.15 pg/mL
Standard Deviation 139.88
|
17.48 pg/mL
Standard Deviation 30.18
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 30
|
—
|
—
|
47.24 pg/mL
Standard Deviation 140.36
|
18.72 pg/mL
Standard Deviation 33.96
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 40
|
0.00 pg/mL
Standard Deviation 0.00
|
191.50 pg/mL
Standard Deviation 270.82
|
—
|
—
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 50
|
0.00 pg/mL
Standard Deviation 0.00
|
46.15 pg/mL
Standard Deviation 65.27
|
—
|
—
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 60
|
18.58 pg/mL
Standard Deviation 37.15
|
0.00 pg/mL
Standard Deviation 0.00
|
44.86 pg/mL
Standard Deviation 135.13
|
17.43 pg/mL
Standard Deviation 29.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 60
|
—
|
—
|
37.12 pg/mL
Standard Deviation 109.15
|
7.80 pg/mL
Standard Deviation 15.60
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 90
|
6.18 pg/mL
Standard Deviation 16.04
|
89.73 pg/mL
Standard Deviation 138.77
|
43.19 pg/mL
Standard Deviation 129.12
|
17.52 pg/mL
Standard Deviation 31.33
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 90
|
5.22 pg/mL
Standard Deviation 17.31
|
87.67 pg/mL
Standard Deviation 136.60
|
52.09 pg/mL
Standard Deviation 152.20
|
14.77 pg/mL
Standard Deviation 24.91
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 120
|
—
|
—
|
45.19 pg/mL
Standard Deviation 134.60
|
14.90 pg/mL
Standard Deviation 25.03
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 120
|
—
|
—
|
44.29 pg/mL
Standard Deviation 124.45
|
17.40 pg/mL
Standard Deviation 30.14
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 150
|
—
|
—
|
42.48 pg/mL
Standard Deviation 129.48
|
4.28 pg/mL
Standard Deviation 10.49
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 150
|
—
|
—
|
45.51 pg/mL
Standard Deviation 132.38
|
4.67 pg/mL
Standard Deviation 11.43
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 180
|
6.52 pg/mL
Standard Deviation 15.24
|
77.83 pg/mL
Standard Deviation 131.64
|
16.67 pg/mL
Standard Deviation 57.74
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 180
|
3.69 pg/mL
Standard Deviation 12.24
|
78.83 pg/mL
Standard Deviation 124.29
|
14.70 pg/mL
Standard Deviation 46.49
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 210
|
—
|
—
|
3.96 pg/mL
Standard Deviation 13.71
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 210
|
—
|
—
|
21.08 pg/mL
Standard Deviation 73.03
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 240
|
—
|
—
|
3.18 pg/mL
Standard Deviation 11.00
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 240
|
—
|
—
|
38.73 pg/mL
Standard Deviation 128.44
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 270
|
0.00 pg/mL
Standard Deviation 0.00
|
96.83 pg/mL
Standard Deviation 168.84
|
22.50 pg/mL
Standard Deviation 77.94
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 270
|
0.00 pg/mL
Standard Deviation 0.00
|
79.33 pg/mL
Standard Deviation 141.85
|
1.85 pg/mL
Standard Deviation 6.15
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 300
|
—
|
—
|
38.91 pg/mL
Standard Deviation 129.05
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 300
|
—
|
—
|
14.60 pg/mL
Standard Deviation 46.17
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 330
|
—
|
—
|
0.00 pg/mL
Standard Deviation 0.00
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 330
|
—
|
—
|
0.00 pg/mL
Standard Deviation 0.00
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 360
|
0.00 pg/mL
Standard Deviation 0.00
|
98.33 pg/mL
Standard Deviation 165.43
|
44.59 pg/mL
Standard Deviation 146.44
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0.25 Hours Day 360
|
0.00 pg/mL
Standard Deviation 0.00
|
130.17 pg/mL
Standard Deviation 265.68
|
31.64 pg/mL
Standard Deviation 104.93
|
0.00 pg/mL
Standard Deviation 0.00
|
|
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)
0 Hour Day 390
|
0.00 pg/mL
Standard Deviation 0.00
|
107.40 pg/mL
Standard Deviation 240.15
|
12.17 pg/mL
Standard Deviation 42.15
|
0.00 pg/mL
Standard Deviation 0.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort M&Q: Pre dose (0 hr) on Day 0, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 0: tau
|
185.70 pg/mL
Standard Deviation 58.11
|
194.00 pg/mL
Standard Deviation 88.75
|
140.93 pg/mL
Standard Deviation 50.96
|
165.83 pg/mL
Standard Deviation 49.77
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 10: tau
|
—
|
—
|
-15.09 pg/mL
Standard Deviation 16.44
|
2.55 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 20: tau
|
—
|
—
|
-11.67 pg/mL
Standard Deviation 12.82
|
4.72 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 30: tau
|
—
|
—
|
6.60 pg/mL
Standard Deviation 17.76
|
4.22 pg/mL
Standard Deviation 1.36
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 40: tau
|
-21.13 pg/mL
Standard Deviation 9.99
|
-4.07 pg/mL
Standard Deviation 3.13
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 50: tau
|
7.70 pg/mL
Standard Deviation 24.02
|
7.92 pg/mL
Standard Deviation 6.19
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 60: tau
|
15.90 pg/mL
Standard Deviation 22.71
|
-10.43 pg/mL
Standard Deviation 3.35
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 90: tau
|
-6.88 pg/mL
Standard Deviation 22.64
|
-9.18 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 180: tau
|
-15.76 pg/mL
Standard Deviation 18.49
|
-37.35 pg/mL
Standard Deviation 13.67
|
-16.47 pg/mL
Standard Deviation 22.01
|
8.60 pg/mL
Standard Deviation 7.16
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 360: tau
|
1.37 pg/mL
Standard Deviation 22.13
|
-2.07 pg/mL
Standard Deviation 19.78
|
-13.15 pg/mL
Standard Deviation 21.38
|
-9.75 pg/mL
Standard Deviation 9.61
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 0: p-tau
|
67.19 pg/mL
Standard Deviation 18.05
|
65.77 pg/mL
Standard Deviation 20.21
|
60.27 pg/mL
Standard Deviation 26.26
|
74.00 pg/mL
Standard Deviation 27.73
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 10: p-tau
|
—
|
—
|
0.25 pg/mL
Standard Deviation 36.71
|
32.52 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 20: p-tau
|
—
|
—
|
24.79 pg/mL
Standard Deviation 73.39
|
34.55 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 30: p-tau
|
—
|
—
|
2.91 pg/mL
Standard Deviation 6.51
|
0.92 pg/mL
Standard Deviation 3.82
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 40: p-tau
|
21.41 pg/mL
Standard Deviation 27.96
|
6.53 pg/mL
Standard Deviation 1.72
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 50: p-tau
|
39.51 pg/mL
Standard Deviation 63.57
|
62.96 pg/mL
Standard Deviation 100.89
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 60: p-tau
|
2.28 pg/mL
Standard Deviation 19.79
|
-3.10 pg/mL
Standard Deviation 10.26
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 90: p-tau
|
16.04 pg/mL
Standard Deviation 24.13
|
-3.95 pg/mL
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluated.
|
—
|
—
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 180: p-tau
|
-8.31 pg/mL
Standard Deviation 29.96
|
-7.45 pg/mL
Standard Deviation 43.56
|
-10.79 pg/mL
Standard Deviation 58.37
|
10.04 pg/mL
Standard Deviation 24.97
|
|
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins
0 Hour Day 360: p-tau
|
4.29 pg/mL
Standard Deviation 38.32
|
24.55 pg/mL
Standard Deviation 35.01
|
8.96 pg/mL
Standard Deviation 68.60
|
-7.31 pg/mL
Standard Deviation 41.09
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 10
|
—
|
—
|
-0.01 gram per liter (g/L)
Standard Deviation 0.013
|
0.01 gram per liter (g/L)
Standard Deviation 0.011
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 20
|
—
|
—
|
0.04 gram per liter (g/L)
Standard Deviation 0.077
|
0.01 gram per liter (g/L)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 30
|
—
|
—
|
0.02 gram per liter (g/L)
Standard Deviation 0.027
|
0.00 gram per liter (g/L)
Standard Deviation 0.014
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 40
|
0.00 gram per liter (g/L)
Standard Deviation 0.015
|
0.02 gram per liter (g/L)
Standard Deviation 0.013
|
—
|
—
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 50
|
0.00 gram per liter (g/L)
Standard Deviation 0.031
|
0.06 gram per liter (g/L)
Standard Deviation 0.064
|
—
|
—
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 60
|
0.02 gram per liter (g/L)
Standard Deviation 0.108
|
0.07 gram per liter (g/L)
Standard Deviation 0.080
|
—
|
—
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 90
|
-0.01 gram per liter (g/L)
Standard Deviation 0.015
|
0.01 gram per liter (g/L)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 180
|
0.04 gram per liter (g/L)
Standard Deviation 0.088
|
0.09 gram per liter (g/L)
Standard Deviation 0.081
|
0.02 gram per liter (g/L)
Standard Deviation 0.029
|
0.04 gram per liter (g/L)
Standard Deviation 0.026
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Change at 0 Hour Day 360
|
0.02 gram per liter (g/L)
Standard Deviation 0.059
|
0.05 gram per liter (g/L)
Standard Deviation 0.056
|
0.00 gram per liter (g/L)
Standard Deviation 0.036
|
0.02 gram per liter (g/L)
Standard Deviation 0.017
|
|
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360
Baseline
|
0.32 gram per liter (g/L)
Standard Deviation 0.091
|
0.30 gram per liter (g/L)
Standard Deviation 0.230
|
0.32 gram per liter (g/L)
Standard Deviation 0.198
|
0.22 gram per liter (g/L)
Standard Deviation 0.050
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Baseline: RBC
|
30.08 10^6 cells per liter
Standard Deviation 83.842
|
1.17 10^6 cells per liter
Standard Deviation 2.041
|
2.58 10^6 cells per liter
Standard Deviation 2.392
|
8.17 10^6 cells per liter
Standard Deviation 12.287
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 10: RBC
|
—
|
—
|
-0.25 10^6 cells per liter
Standard Deviation 0.500
|
67.50 10^6 cells per liter
Standard Deviation 95.459
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 20: RBC
|
—
|
—
|
80.50 10^6 cells per liter
Standard Deviation 141.576
|
-18.00 10^6 cells per liter
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 30: RBC
|
—
|
—
|
12.75 10^6 cells per liter
Standard Deviation 25.513
|
1.50 10^6 cells per liter
Standard Deviation 2.121
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 40: RBC
|
-75.75 10^6 cells per liter
Standard Deviation 146.227
|
0.50 10^6 cells per liter
Standard Deviation 0.707
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 50: RBC
|
-4.50 10^6 cells per liter
Standard Deviation 9.000
|
0.00 10^6 cells per liter
Standard Deviation 0.000
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 90: RBC
|
-70.75 10^6 cells per liter
Standard Deviation 149.295
|
-1.00 10^6 cells per liter
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 180: RBC
|
72.00 10^6 cells per liter
Standard Deviation 191.426
|
1.75 10^6 cells per liter
Standard Deviation 2.217
|
6.25 10^6 cells per liter
Standard Deviation 15.516
|
24.60 10^6 cells per liter
Standard Deviation 62.528
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 360: RBC
|
-26.67 10^6 cells per liter
Standard Deviation 84.610
|
21.83 10^6 cells per liter
Standard Deviation 37.870
|
26.67 10^6 cells per liter
Standard Deviation 74.644
|
-6.80 10^6 cells per liter
Standard Deviation 9.960
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Baseline: WBC
|
1.34 10^6 cells per liter
Standard Deviation 1.310
|
0.98 10^6 cells per liter
Standard Deviation 1.250
|
1.47 10^6 cells per liter
Standard Deviation 1.798
|
1.42 10^6 cells per liter
Standard Deviation 1.563
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 10: WBC
|
—
|
—
|
0.50 10^6 cells per liter
Standard Deviation 2.517
|
0.00 10^6 cells per liter
Standard Deviation 0.000
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 20: WBC
|
—
|
—
|
0.50 10^6 cells per liter
Standard Deviation 1.000
|
0.00 10^6 cells per liter
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 30: WBC
|
—
|
—
|
0.00 10^6 cells per liter
Standard Deviation 0.000
|
-0.30 10^6 cells per liter
Standard Deviation 0.424
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 40: WBC
|
0.75 10^6 cells per liter
Standard Deviation 0.957
|
-0.50 10^6 cells per liter
Standard Deviation 0.707
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 60: WBC
|
-0.48 10^6 cells per liter
Standard Deviation 0.618
|
0.30 10^6 cells per liter
Standard Deviation 0.424
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 90: WBC
|
1.00 10^6 cells per liter
Standard Deviation 1.155
|
-1.00 10^6 cells per liter
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 180: WBC
|
-0.35 10^6 cells per liter
Standard Deviation 0.862
|
-0.33 10^6 cells per liter
Standard Deviation 1.087
|
0.06 10^6 cells per liter
Standard Deviation 0.876
|
0.14 10^6 cells per liter
Standard Deviation 0.699
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 60: RBC
|
2.50 10^6 cells per liter
Standard Deviation 8.660
|
0.00 10^6 cells per liter
Standard Deviation 0.000
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 50: WBC
|
0.35 10^6 cells per liter
Standard Deviation 1.814
|
-0.65 10^6 cells per liter
Standard Deviation 0.919
|
—
|
—
|
|
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 360: WBC
|
-0.04 10^6 cells per liter
Standard Deviation 2.097
|
-0.48 10^6 cells per liter
Standard Deviation 0.801
|
0.22 10^6 cells per liter
Standard Deviation 0.944
|
0.14 10^6 cells per liter
Standard Deviation 1.182
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively.
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 Participants
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 Participants
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Baseline
|
3.47 millimole per liter (mmol/L)
Standard Deviation 0.267
|
3.40 millimole per liter (mmol/L)
Standard Deviation 0.438
|
3.41 millimole per liter (mmol/L)
Standard Deviation 0.188
|
3.35 millimole per liter (mmol/L)
Standard Deviation 0.288
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 10
|
—
|
—
|
0.00 millimole per liter (mmol/L)
Standard Deviation 0.082
|
-0.20 millimole per liter (mmol/L)
Standard Deviation 0.141
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 20
|
—
|
—
|
0.03 millimole per liter (mmol/L)
Standard Deviation 0.126
|
-0.10 millimole per liter (mmol/L)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 30
|
—
|
—
|
-0.03 millimole per liter (mmol/L)
Standard Deviation 0.206
|
0.00 millimole per liter (mmol/L)
Standard Deviation 0.141
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 40
|
-0.10 millimole per liter (mmol/L)
Standard Deviation 0.141
|
0.10 millimole per liter (mmol/L)
Standard Deviation 0.283
|
—
|
—
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 50
|
-0.08 millimole per liter (mmol/L)
Standard Deviation 0.171
|
0.05 millimole per liter (mmol/L)
Standard Deviation 0.071
|
—
|
—
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 60
|
-0.08 millimole per liter (mmol/L)
Standard Deviation 0.275
|
-0.30 millimole per liter (mmol/L)
Standard Deviation 0.283
|
—
|
—
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 90
|
0.00 millimole per liter (mmol/L)
Standard Deviation 0.216
|
0.00 millimole per liter (mmol/L)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
—
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 180
|
-0.01 millimole per liter (mmol/L)
Standard Deviation 0.295
|
-0.18 millimole per liter (mmol/L)
Standard Deviation 0.411
|
-0.01 millimole per liter (mmol/L)
Standard Deviation 0.156
|
0.00 millimole per liter (mmol/L)
Standard Deviation 0.187
|
|
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360
Change at 0 Hour Day 360
|
-0.03 millimole per liter (mmol/L)
Standard Deviation 0.246
|
0.00 millimole per liter (mmol/L)
Standard Deviation 0.358
|
0.58 millimole per liter (mmol/L)
Standard Deviation 1.012
|
0.04 millimole per liter (mmol/L)
Standard Deviation 0.182
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 up to Month 18Population: Safety analysis set included all randomized participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 were to be analyzed for this outcome measure.
A measurable ADA is defined as a serum anti-drug anti body response (total binding assay) greater than the lower limit of quantification (4.32).
Outcome measures
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 Participants
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=12 Participants
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Number of Participants With Measurable Serum Anti-Drug Antibody (ADA) Concentration
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
PF-04360365 10 mg/kg (Cohort Q)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo (Cohort Q)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo (Cohort M)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 participants at risk
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 participants at risk
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 participants at risk
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 participants at risk
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
Other adverse events
| Measure |
PF-04360365 10 mg/kg (Cohort Q)
n=12 participants at risk
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
Placebo (Cohort Q)
n=6 participants at risk
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.
|
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)
n=12 participants at risk
Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
Placebo (Cohort M)
n=6 participants at risk
Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Eye disorders
Diplopia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Eye disorders
Vision blurred
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
General disorders
Facial pain
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
General disorders
Irritability
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
General disorders
Oedema
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
General disorders
Oedema peripheral
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
General disorders
Pyrexia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
General disorders
Tenderness
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Infections and infestations
Influenza
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
50.0%
3/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Infections and infestations
Urinary tract infection
|
25.0%
3/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
50.0%
3/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Blood pressure decreased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Blood pressure increased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Investigations
Weight decreased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Nervous system disorders
Areflexia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Nervous system disorders
Headache
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Nervous system disorders
Syncope
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Psychiatric disorders
Depression
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Vascular disorders
Haematoma
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Vascular disorders
Hypertension
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
33.3%
4/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER