Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00787319
• Collaborator: (none)
• Enrollment: 108
• Locations: 11
• Duration (Months): 29
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration	Other: no intervention

Detailed Description

no sampling

Study Design

• Study Type: Observational
• Actual Enrollment: 108 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
AMD	Other: no intervention; Outpatients with age-related macular degeneration (AMD); Other Names: observation only

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Visual Acuity (VA) at Final Visit [Baseline, Final Visit (Week 104 or early termination [ET])]

   Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.

Secondary Outcome Measures

1. Change From Baseline in Visual Acuity (VA) at Each Visit [Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102]

   VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.

2. Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination [Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102]

   VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.

3. Physician's Assessment of Efficacy [Week 104 or End of study (EOS)]

   Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.

Other Outcome Measures

1. Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring [Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102]

   Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.

2. Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs) [Baseline up to Week 104 (EOS)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

3. Duration of Treatment [Baseline up to Week 104 (EOS)]

   Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.

4. Mean Number of Doses of Study Medication Received [Baseline up to Week 104 (EOS)]

5. Physician's Assessment of Tolerability [Baseline up to Week 104 (EOS)]

   Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age over 18 years old

• patients with neovascular age-related macular degeneration

• enrollment to study is fully on physician decision in compliance with current SPC

Exclusion Criteria:

• Patient who did not meet indication according to SPC Macugen.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Brno		Czechia	625 00
2	Pfizer Investigational Site	Brno		Czechia	62500
3	Pfizer Investigational Site	Olomouc		Czechia	775 20
4	Pfizer Investigational Site	Olomouc		Czechia	77520
5	Pfizer Investigational Site	Ostrava - Poruba		Czechia	70852
6	Pfizer Investigational Site	Plzen		Czechia	304 60
7	Pfizer Investigational Site	Praha 2		Czechia	128 08
8	Pfizer Investigational Site	Praha 2		Czechia	12808
9	Pfizer Investigational Site	Praha 6		Czechia	169 00
10	Pfizer Investigational Site	Praha 6		Czechia	169 02
11	Pfizer Investigational Site	Usti nad Labem		Czechia	40113

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00787319
• Other Study ID Numbers: A5751032
• First Posted: Nov 7, 2008
• Last Update Posted: Dec 6, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Pfizer: Ophthalmology; Age-related macular degeneration; outpatients
• Additional relevant MeSH terms: Macular Degeneration

Study Results

Participant Flow

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Period Title: Overall Study
STARTED	108
COMPLETED	45
NOT COMPLETED	63

Baseline Characteristics

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Overall Participants	108
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.8 (8.3)
Sex: Female, Male (Count of Participants)
Female	65 60.2%
Male	43 39.8%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Visual Acuity (VA) at Final Visit
Description	Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.
Time Frame	Baseline, Final Visit (Week 104 or early termination [ET])

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS) included all enrolled participants who received study medication. Missing values were imputed using last observation carried forward (LOCF) method.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	108
Baseline	0.61 (0.27)
Change at Final visit	0.15 (0.37)

2. Secondary Outcome

Title	Change From Baseline in Visual Acuity (VA) at Each Visit
Description	VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.
Time Frame	Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies participants evaluated at each time point, respectively.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	93
Change at Week 6 (n=93)	-0.03 (0.13)
Change at Week 12 (n=88)	0.03 (0.23)
Change at Week 18 (n=76)	0.03 (0.27)
Change at Week 24 (n=75)	0.01 (0.27)
Change at Week 30 (n=74)	0.03 (0.26)
Change at Week 36 (n=68)	0.02 (0.29)
Change at Week 42 (n=59)	0.06 (0.28)
Change at Week 48 (n=68)	0.10 (0.35)
Change at Week 54 (n=50)	0.09 (0.35)
Change at Week 60 (n=46)	0.10 (0.35)
Change at Week 66 (n=25)	0.10 (0.41)
Change at Week 72 (n=19)	0.14 (0.51)
Change at Week 78 (n=20)	0.19 (0.37)
Change at Week 84 (n=13)	0.05 (0.35)
Change at Week 90 (n=16)	-0.05 (0.24)
Change at Week 96 (n=11)	-0.10 (0.28)
Change at Week 102 (n=20)	0.16 (0.37)

3. Secondary Outcome

Title	Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Description	VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.
Time Frame	Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies participants evaluated at each time point, respectively.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	90
Week 6: Improved (n=90)	20 18.5%
Week 6: Unchanged (n=90)	64 59.3%
Week 6: Worsened (n=90)	6 5.6%
Week 12: Improved (n=88)	12 11.1%
Week 12: Unchanged (n=88)	58 53.7%
Week 12: Worsened (n=88)	18 16.7%
Week 18: Improved (n=72)	12 11.1%
Week 18: Unchanged (n=72)	49 45.4%
Week 18: Worsened (n=72)	11 10.2%
Week 24: Improved (n=73)	16 14.8%
Week 24: Unchanged (n=73)	46 42.6%
Week 24: Worsened (n=73)	11 10.2%
Week 30: Improved (n=74)	9 8.3%
Week 30: Unchanged (n=74)	51 47.2%
Week 30: Worsened (n=74)	14 13%
Week 36: Improved (n=68)	11 10.2%
Week 36: Unchanged (n=68)	47 43.5%
Week 36: Worsened (n=68)	10 9.3%
Week 42: Improved (n=59)	8 7.4%
Week 42: Unchanged (n=59)	42 38.9%
Week 42: Worsened (n=59)	9 8.3%
Week 48: Improved (n=68)	12 11.1%
Week 48: Unchanged (n=68)	44 40.7%
Week 48: Worsened (n=68)	12 11.1%
Week 54: Improved (n=50)	8 7.4%
Week 54: Unchanged (n=50)	33 30.6%
Week 54: Worsened (n=50)	9 8.3%
Week 60: Improved (n=46)	1 0.9%
Week 60: Unchanged (n=46)	38 35.2%
Week 60: Worsened (n=46)	7 6.5%
Week 66: Improved (n=25)	3 2.8%
Week 66: Unchanged (n=25)	11 10.2%
Week 66: Worsened (n=25)	11 10.2%
Week 72: Improved (n=18)	4 3.7%
Week 72: Unchanged (n=18)	12 11.1%
Week 72: Worsened (n=18)	2 1.9%
Week 78: Improved (n=20)	2 1.9%
Week 78: Unchanged (n=20)	14 13%
Week 78: Worsened (n=20)	4 3.7%
Week 84: Improved (n=13)	2 1.9%
Week 84: Unchanged (n=13)	8 7.4%
Week 84: Worsened (n=13)	3 2.8%
Week 90: Improved (n=16)	4 3.7%
Week 90: Unchanged (n=16)	10 9.3%
Week 90: Worsened (n=16)	2 1.9%
Week 96: Improved (n=11)	5 4.6%
Week 96: Unchanged (n=11)	4 3.7%
Week 96: Worsened (n=11)	2 1.9%
Week 102: Improved (n=20)	3 2.8%
Week 102: Unchanged (n=20)	8 7.4%
Week 102: Worsened (n=20)	9 8.3%

4. Secondary Outcome

Title	Physician's Assessment of Efficacy
Description	Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.
Time Frame	Week 104 or End of study (EOS)

Outcome Measure Data

Analysis Population Description

FAS included all enrolled participants who received study medication.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	108
Excellent	20 18.5%
Very Good	16 14.8%
Good	24 22.2%
Fair	12 11.1%
Poor	36 33.3%

5. Other Pre-specified Outcome

Title	Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Description	Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.
Time Frame	Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

Outcome Measure Data

Analysis Population Description

Safety analysis set included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies participants evaluated at each time point, respectively.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	87
Baseline: Diagnosis,OCT (n=87)	85 78.7%
Baseline: Diagnosis,FA (n=87)	61 56.5%
Baseline: Diagnosis,Ot (n=87)	12 11.1%
Baseline: Monitoring,OCT (n=25)	25 23.1%
Baseline: Monitoring,FA (n=25)	6 5.6%
Baseline: Monitoring,Ot (n=25)	1 0.9%
Week 6: Monitoring,OCT (n=21)	21 19.4%
Week 12: Monitoring,OCT (n=32)	32 29.6%
Week 18: Monitoring,OCT (n=20)	20 18.5%
Week 18: Monitoring,Ot (n=20)	1 0.9%
Week 24: Monitoring,OCT (n=23)	23 21.3%
Week 24: Monitoring,FA (n=23)	1 0.9%
Week 24: Monitoring,Ot (n=23)	1 0.9%
Week 30: Monitoring,OCT (n=20)	20 18.5%
Week 30: Monitoring,Ot (n=20)	1 0.9%
Week 36: Monitoring,OCT (n=21)	20 18.5%
Week 36: Monitoring,Ot (n=21)	1 0.9%
Week 42: Monitoring,OCT (n=14)	14 13%
Week 48: Monitoring,OCT (n=19)	19 17.6%
Week 54: Diagnosis,OCT (n=2)	1 0.9%
Week 54: Diagnosis,FA (n=2)	2 1.9%
Week 54: Monitoring,OCT (n=18)	18 16.7%
Week 54: Monitoring,FA (n=18)	2 1.9%
Week 60: Monitoring,OCT (n=13)	13 12%
Week 60: Monitoring,FA (n=13)	1 0.9%
Week 60: Monitoring,Ot (n=13)	1 0.9%
Week 66: Monitoring,OCT (n=3)	3 2.8%
Week 72: Monitoring,OCT (n=6)	6 5.6%
Week 72: Monitoring,Ot (n=6)	1 0.9%
Week 78: Monitoring,OCT (n=10)	10 9.3%
Week 78: Monitoring,Ot (n=10)	2 1.9%
Week 84: Monitoring,OCT (n=11)	10 9.3%
Week 84: Monitoring,FA (n=11)	1 0.9%
Week 84: Monitoring,Ot (n=11)	1 0.9%
Week 90: Diagnosis,OCT (n=1)	1 0.9%
Week 90: Diagnosis,Ot (n=1)	1 0.9%
Week 90: Monitoring,OCT (n=10)	10 9.3%
Week 90: Monitoring,Ot (n=10)	5 4.6%
Week 96: Monitoring,OCT (n=8)	8 7.4%
Week 96: Monitoring,Ot (n=8)	2 1.9%
Week 102: Diagnosis,OCT (n=1)	1 0.9%
Week 102: Diagnosis,FA (n=1)	1 0.9%
Week 102: Monitoring,OCT (n=17)	12 11.1%
Week 102: Monitoring,FA (n=17)	1 0.9%
Week 102: Monitoring,Ot (n=17)	11 10.2%

6. Other Pre-specified Outcome

Title	Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame	Baseline up to Week 104 (EOS)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all enrolled participants who received study medication.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	108
Number [participants]	3 2.8%

7. Other Pre-specified Outcome

Title	Duration of Treatment
Description	Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.
Time Frame	Baseline up to Week 104 (EOS)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all enrolled participants who received study medication.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	108
Mean (Standard Deviation) [weeks]	50.33 (29.40)

8. Other Pre-specified Outcome

Title	Mean Number of Doses of Study Medication Received
Time Frame	Baseline up to Week 104 (EOS)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all enrolled participants who received study medication.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	108
Mean (Standard Deviation) [doses]	7.48 (3.77)

9. Other Pre-specified Outcome

Title	Physician's Assessment of Tolerability
Description	Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.
Time Frame	Baseline up to Week 104 (EOS)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all enrolled participants who received study medication.

Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
Measure Participants	108
Excellent	64 59.3%
Very Good	34 31.5%
Good	8 7.4%
Fair	2 1.9%
Poor	0 0%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Pegaptanib
Arm/Group Description	Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
All Cause Mortality
	Pegaptanib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pegaptanib
	Affected / at Risk (%)	# Events
Total	2/108 (1.9%)
Eye disorders
Choroidal neovascularisation	1/108 (0.9%)
Injury, poisoning and procedural complications
Femur fracture	1/108 (0.9%)
Other (Not Including Serious) Adverse Events
	Pegaptanib
	Affected / at Risk (%)	# Events
Total	22/108 (20.4%)
Eye disorders
Age-related macular degeneration	4/108 (3.7%)
Choroidal neovascularisation	3/108 (2.8%)
Conjunctivitis	4/108 (3.7%)
Corneal erosion	1/108 (0.9%)
Glaucoma	1/108 (0.9%)
Macular oedema	1/108 (0.9%)
Retinal haemorrhage	2/108 (1.9%)
Subretinal fibrosis	1/108 (0.9%)
General disorders
Drug ineffective	1/108 (0.9%)
Granuloma	1/108 (0.9%)
Infections and infestations
Conjunctivitis bacterial	1/108 (0.9%)
Keratitis herpetic	1/108 (0.9%)
Oral herpes	1/108 (0.9%)
Viral infection	1/108 (0.9%)
Injury, poisoning and procedural complications
Lower limb fracture	1/108 (0.9%)
Nervous system disorders
Dizziness	1/108 (0.9%)
Surgical and medical procedures
Therapeutic embolisation	1/108 (0.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.