Trial Outcomes & Findings for Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy (NCT NCT01821118)
NCT ID: NCT01821118
Last Updated: 2017-05-10
Results Overview
Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline, Day 2
Results posted on
2017-05-10
Participant Flow
Participant milestones
| Measure |
PF-04360365
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
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|---|---|---|
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Overall Study
STARTED
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24
|
12
|
|
Overall Study
COMPLETED
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24
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PF-04360365
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
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|---|---|---|
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Overall Study
Death
|
0
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1
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Baseline Characteristics
Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy
Baseline characteristics by cohort
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
Total
n=36 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
68.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
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65.0 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 2Population: The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified region of interest (ROI) at Day 2.
Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
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|---|---|---|
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Change From Baseline to Day 2 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked Functional Magnetic Resonance Imaging (fMRI)
Region of interest (ROI) 1 (n=20, 11)
|
0.954 percent/second
Standard Error 0.085
|
0.969 percent/second
Standard Error 0.073
|
|
Change From Baseline to Day 2 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked Functional Magnetic Resonance Imaging (fMRI)
ROI2 (n=23, 11)
|
0.933 percent/second
Standard Error 0.050
|
0.999 percent/second
Standard Error 0.055
|
PRIMARY outcome
Timeframe: Baseline, Day 90Population: The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at Day 90.
BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
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Change From Baseline to Day 90 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked fMRI
ROI1 (n=20, 10)
|
0.817 percent/second
Standard Error 0.064
|
0.958 percent/second
Standard Error 0.063
|
|
Change From Baseline to Day 90 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked fMRI
ROI2 (n=23, 10)
|
0.857 percent/second
Standard Error 0.055
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0.950 percent/second
Standard Error 0.060
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 90Population: The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.
BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI
ROI1, Day 2 (n=20, 11)
|
1.012 seconds
Standard Error 0.028
|
1.007 seconds
Standard Error 0.037
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI
ROI1, Day 90 (n=20, 10)
|
1.065 seconds
Standard Error 0.020
|
1.015 seconds
Standard Error 0.030
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI
ROI2, Day 2 (n=23, 11)
|
1.008 seconds
Standard Error 0.018
|
1.010 seconds
Standard Error 0.026
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI
ROI2, Day 90 (n=23, 10)
|
1.039 seconds
Standard Error 0.018
|
1.028 seconds
Standard Error 0.026
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 90Population: The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.
BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI
ROI1, Day 2 (n=20, 11)
|
-0.0381 percent
90% Confidence Interval 0.028 • Interval -0.1655 to 0.0894
|
-0.0983 percent
90% Confidence Interval 0.037 • Interval -0.2715 to 0.075
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI
ROI1, Day 90 (n=20, 10)
|
-0.1389 percent
90% Confidence Interval 0.020 • Interval -0.2513 to -0.0264
|
-0.053 percent
90% Confidence Interval 0.030 • Interval -0.2135 to 0.1075
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI
ROI2, Day 2 (n=23, 11)
|
-0.0714 percent
90% Confidence Interval 0.018 • Interval -0.1584 to 0.0156
|
-0.0226 percent
90% Confidence Interval 0.026 • Interval -0.1484 to 0.1033
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI
ROI2, Day 90 (n=23, 10)
|
-0.1245 percent
90% Confidence Interval 0.018 • Interval -0.2236 to -0.0254
|
-0.0357 percent
90% Confidence Interval 0.026 • Interval -0.1861 to 0.1146
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 90Population: The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.
BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI
ROI1, Day 2 (n=20, 11)
|
0.0245 seconds
90% Confidence Interval 0.028 • Interval -0.0155 to 0.0644
|
-0.022 seconds
90% Confidence Interval 0.037 • Interval -0.0759 to 0.0319
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI
ROI1, Day 90 (n=20, 10)
|
0.0558 seconds
90% Confidence Interval 0.020 • Interval 0.0182 to 0.0934
|
-0.0179 seconds
90% Confidence Interval 0.030 • Interval -0.0711 to 0.0354
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI
ROI2, Day 2 (n=23, 11)
|
0.0045 seconds
90% Confidence Interval 0.018 • Interval -0.028 to 0.0369
|
-0.0174 seconds
90% Confidence Interval 0.026 • Interval -0.0643 to 0.0295
|
|
Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI
ROI2, Day 90 (n=23, 10)
|
0.0275 seconds
90% Confidence Interval 0.018 • Interval -0.004 to 0.0589
|
0.0158 seconds
90% Confidence Interval 0.026 • Interval -0.0322 to 0.0637
|
SECONDARY outcome
Timeframe: Baseline, 8 hours post dose on Day 1, Day 2, Day 30, 90 and 240Population: All 36 participants who received study treatment were included in this pharmacodynamic analysis. n=number of participants with measurable AB at the specified time point.
Cerebral amyloid angiopathy (CAA) is caused by the progressive deposition of amyloid, predominantly AB40, within the walls of cerebral blood vessels with a predisposition for the vessels of the occipital lobe. As such, it is of interest to investigate the effect of PF-04360365 on AB concentrations. AB1-x and AB1-40 were investigated.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
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|---|---|---|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-x, Day 1 (n=4, 3)
|
4374.0 picograms (pg)/milliliter (mL)
Standard Deviation 420.62
|
5.3 picograms (pg)/milliliter (mL)
Standard Deviation 26.01
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-x, Day 2 (n=4, 3)
|
13911.8 picograms (pg)/milliliter (mL)
Standard Deviation 3292.88
|
-37.7 picograms (pg)/milliliter (mL)
Standard Deviation 29.02
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-x, Day 30 (n=4, 3)
|
94468.5 picograms (pg)/milliliter (mL)
Standard Deviation 11946.21
|
-48.3 picograms (pg)/milliliter (mL)
Standard Deviation 103.32
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-x, Day 90 (n=4, 2)
|
111312.8 picograms (pg)/milliliter (mL)
Standard Deviation 24677.74
|
-62.0 picograms (pg)/milliliter (mL)
Standard Deviation 141.42
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-x, Day 240 (n=4, 3)
|
30495.8 picograms (pg)/milliliter (mL)
Standard Deviation 10931.16
|
13.0 picograms (pg)/milliliter (mL)
Standard Deviation 116.76
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-40, Day 1 (n=23, 11)
|
4747.6 picograms (pg)/milliliter (mL)
Standard Deviation 1039.96
|
-8.4 picograms (pg)/milliliter (mL)
Standard Deviation 30.08
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-40, Day 2 (n=23, 11)
|
12845.2 picograms (pg)/milliliter (mL)
Standard Deviation 2887.91
|
0.5 picograms (pg)/milliliter (mL)
Standard Deviation 30.90
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-40, Day 30 (n=23, 10)
|
68010.1 picograms (pg)/milliliter (mL)
Standard Deviation 17396.04
|
-5.0 picograms (pg)/milliliter (mL)
Standard Deviation 46.81
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-40, Day 90 (n=23, 10)
|
87710.8 picograms (pg)/milliliter (mL)
Standard Deviation 18699.28
|
0.7 picograms (pg)/milliliter (mL)
Standard Deviation 44.02
|
|
Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)
AB1-40, Day 240 (n=23, 9)
|
20665.6 picograms (pg)/milliliter (mL)
Standard Deviation 7132.91
|
-6.2 picograms (pg)/milliliter (mL)
Standard Deviation 35.63
|
SECONDARY outcome
Timeframe: Baseline/Screening, Day 15, Day 45, Day 90,Population: All 36 participants who received study treatment were analyzed for this endpoint.
Brain sMRI abnormalities included cerebral edema and total infarcts (including cortical infarcts, white matter infarcts, and subcortical gray matter infarcts). "Total infarcts" is the total number of participants with at least 1 type of infarct.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
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|---|---|---|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Subcortical gray matter infarcts, Day 45
|
3 participants
|
1 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cerebral edema, Screening
|
0 participants
|
1 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cerebral edema, Day 15
|
0 participants
|
1 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cerebral edema, Day 45
|
0 participants
|
1 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cerebral edema, Day 90
|
1 participants
|
1 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Total infarcts, Screening
|
5 participants
|
3 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Total infarcts, Day 15
|
5 participants
|
3 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Total infarcts, Day 45
|
5 participants
|
3 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Total infarcts, Day 90
|
5 participants
|
3 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cortical infarcts, Screening
|
0 participants
|
0 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cortical infarcts, Day 15
|
0 participants
|
0 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cortical infarcts, Day 45
|
0 participants
|
0 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Cortical infarcts, Day 90
|
0 participants
|
0 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
White matter infarcts, Screening
|
3 participants
|
2 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
White matter infarcts, Day 15
|
3 participants
|
2 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
White matter infarcts, Day 45
|
3 participants
|
2 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
White matter infarcts, Day 90
|
3 participants
|
2 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Subcortical gray matter infarcts, Screening
|
3 participants
|
1 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Subcortical gray matter infarcts, Day 15
|
3 participants
|
1 participants
|
|
Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities
Subcortical gray matter infarcts, Day 90
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Screening; Days 0, 1, 30, 60, 90, and 240Population: All 36 participants who received study treatment were included in the analysis. On Day 240, the number of evaluable participants in the placebo group was 11 instead of 12.
The Montreal Cognitive Assessment (MoCA) was used as a safety outcome measure to assess any changes in cognition. The MoCA is a 1-page 30-point test administered in approximately 10 minutes. The MoCA assessed short term memory, visuospatial abilities, multiple aspects of executive functions, attention, concentration, working memory, and language, as well as orientation to time and place. The total scale ranges from 0 to 30, with lower numbers indicating lower cognition performance.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time
Screening
|
25.4 units on a scale
Standard Deviation 4.24
|
25.9 units on a scale
Standard Deviation 1.73
|
|
Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time
Day 0
|
25.5 units on a scale
Standard Deviation 3.41
|
25.9 units on a scale
Standard Deviation 3.34
|
|
Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time
Day 1
|
25.1 units on a scale
Standard Deviation 3.10
|
25.8 units on a scale
Standard Deviation 2.73
|
|
Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time
Day 30
|
27.0 units on a scale
Standard Deviation 2.46
|
26.8 units on a scale
Standard Deviation 2.53
|
|
Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time
Day 60
|
26.6 units on a scale
Standard Deviation 3.12
|
26.8 units on a scale
Standard Deviation 3.33
|
|
Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time
Day 90
|
26.0 units on a scale
Standard Deviation 3.46
|
26.7 units on a scale
Standard Deviation 3.14
|
|
Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time
Day 240
|
26.1 units on a scale
Standard Deviation 3.43
|
26.5 units on a scale
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Baseline up to Day 240Population: All 36 participants who received study drug were included in the AE summarization/analysis.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
All causality TEAEs
|
16 participants
|
8 participants
|
|
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
Treatment-related TEAEs
|
2 participants
|
2 participants
|
|
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
All causality SAEs
|
2 participants
|
2 participants
|
|
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
Treatment-related SAEs
|
0 participants
|
1 participants
|
|
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
All causality severe TEAEs
|
2 participants
|
2 participants
|
|
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
Treatment-related severe TEAEs
|
0 participants
|
1 participants
|
|
Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)
Discontinued due to all causality TEAEs
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 240Population: All 36 participants who received study drug were included in the analysis.
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function (including Hy's Law Criteria), renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
14 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 240Population: All 36 participants who received study drug were included in the analysis.
Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of less than (\<)90 millimeters of mercury (mm Hg) or more than (\>) 160 mm Hg; supine diastolic blood pressure (DBP) \<50 mm Hg or \>100 mm Hg; supine pulse rate of \<60 beats per minute (bpm) or \>100 bpm; maximum changes (increase or decrease) from baseline in supine SBP of \>=20 mm Hg; maximum increase from baseline in supine DBP of \>=20 mm Hg; and maximum decrease from baseline in supine DBP of \>=10 mm Hg.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Supine DBP <50 mm Hg
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Supine SBP >160 mm Hg
|
2 participants
|
2 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Supine SBP <90 mm Hg
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Supine DBP >100 mm Hg
|
0 participants
|
1 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Supine pulse rate <60 bpm
|
16 participants
|
7 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Supine pulse rate >100 bpm
|
0 participants
|
1 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Increase from baseline in supine SBP >=20 mm Hg
|
6 participants
|
4 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Increase from baseline in supine DBP >=20 mm Hg
|
1 participants
|
1 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Decrease from baseline in supine SBP >=20 mm Hg
|
9 participants
|
6 participants
|
|
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Decrease from baseline in supine DBP >=10 mm Hg
|
13 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 240Population: All 36 participants who received study drug were included in the analysis.
C-SSRS assessed whether participant responded "yes" to the following: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, self-injurious behavior with no suicidal intent.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)
Completed suicide
|
0 participants
|
0 participants
|
|
Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)
Suicide attempt
|
0 participants
|
0 participants
|
|
Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)
Preparatory acts to imminent suicidal behaviour
|
0 participants
|
0 participants
|
|
Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)
Self-injurious behaviour, no suicidal intent
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Final Visit (Day 240)Population: All 36 participants who received study drug were included in the analysis.
A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Number of Participants With Significant Changes From Baseline in Physical Examination at Final Visit
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up till Day 240Population: All 36 participants who received study drug were included in the analysis.
A complete/full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 Participants
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Number of Participants With Significant Changes in Neurological Examination Results
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 240Population: All 24 participants who received PF-04360365 were included in this analysis.
Blood samples were collected from participants who received active treatment to assess for presence/absence of anti-PF-04360365 antibodies.
Outcome measures
| Measure |
PF-04360365
n=24 Participants
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Number of Participants With Anti-PF-04360365 Antibodies
|
0 participants
|
—
|
Adverse Events
PF-04360365
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04360365
n=24 participants at risk
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 participants at risk
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Aphasia
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Cerebral haemorrhage
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
Other adverse events
| Measure |
PF-04360365
n=24 participants at risk
Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
|
Placebo
n=12 participants at risk
Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Eye disorders
Dry eye
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Eye disorders
Vitreous floaters
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Fatigue
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Gait disturbance
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Fungal skin infection
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Influenza
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
3/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
16.7%
2/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
2/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Haemoglobin decreased
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
2/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Aphasia
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Balance disorder
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Cerebellar syndrome
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Coordination abnormal
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Migraine
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Presyncope
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Superficial siderosis of central nervous system
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Psychiatric disorders
Emotional disorder
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Reproductive system and breast disorders
Testicular cyst
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
8.3%
1/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
4.2%
1/24 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/12 • Adverse events (AEs) and serious AEs (SAEs) monitoring started from screening through and including 28 calendar days after the last administration of the investigational product.
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and a nonserious event during the study.
|
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