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Trial record 9 of 43 for:    "Hemophilia" | "Antibodies"

Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting

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ClinicalTrials.gov Identifier: NCT00950170
Recruitment Status : Completed
First Posted : July 31, 2009
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hemophilia A
Intervention Procedure: Laboratory Tests
Enrollment 23
Recruitment Details A total of 23 participants were enrolled in this non-randomized open-label study & they received ReFacto albumin free (AF) at dose & frequency prescribed by each participant’s treating physician as per local standard of care & in accordance with summary of product characteristics (SmPC). Participants were expected to be in study for about 26 months
Pre-assignment Details The study was conducted at 11 centers across various countries. Participants less than 6 years of age with severe hemophilia A (FVIII activity in plasma [FVIII:C]<1%) who had not received any prior factor products or blood products for their hemophilia A were enrolled in this study.
Arm/Group Title Overall Participants
Hide Arm/Group Description All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
Period Title: Overall Study
Started 23
Completed 19
Not Completed 4
Reason Not Completed
Parent/Legal Guardian Request             1
Adverse Event             2
Discontinuation of Study by Sponsor             1
Arm/Group Title Overall Participants
Hide Arm/Group Description All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
All enrolled subjects who took at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
1.0  (1.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
0
   0.0%
Male
23
 100.0%
1.Primary Outcome
Title Percentage of Participants Who Developed Clinically Significant Factor VIII (FVIII) Inhibitors During the Course of the Study
Hide Description Percentage of participants who developed clinically significant FVIII inhibitors: those persistent over a defined period with clinically impactful effects like breakthrough bleed, low recovery, etc., during the course of the study.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis set included all participants who had received at least 1 dose of ReFacto AF and those were observed for clinically significant FVIII inhibitors.
Arm/Group Title Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
21.74
(7.46 to 43.70)
2.Secondary Outcome
Title Annualized Bleeding Rate (ABR)
Hide Description Annualized bleeding rate was calculated as the number of bleeds divided by the treatment interval duration (enrollment visit to final visit) and then multiplied by 365.25. If there was more than 1 bleed location (like ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: bleeds per year
5.88  (8.082)
3.Secondary Outcome
Title Total Number of Infusions to Treat a New Bleed Classified on Basis of Response to First On-Demand Treatment With Refacto AF
Hide Description Number of infusions of Refacto AF required to treat a new bleed were classified on basis of the response to at 4-point response scale of assessment (excellent, good, moderate and no response). Assessment was completed each time a participant experienced a new bleed requiring an ‘on-demand’ IV infusion. Excellent: definite pain relief and/or improvement in bleeding signs within 8 hours (hr) after infusion, no additional infusion administered; Good: definite pain relief and/or improvement in bleeding signs within 8 hr after infusion, at least 1 additional infusion administered for complete resolution or with no additional infusion administered; Moderate: probable or slight improvement starting after 8 hr following infusion, at least 1 additional infusion administered for complete resolution; No Response: no improvement at all between infusions or during 24 hr interval following infusion or condition worsen. Bleeds for which response not recorded, reported as: Data Not Recorded.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: First IV Infusion Per Bleed Overall Participants: Follow-up IV Infusions Overall Participants: All IV Infusions
Hide Arm/Group Description:
First IV infusions of ReFacto AF received by the participants for on-demand treatment of new bleed.
Follow-up IV infusions of ReFacto AF received by the participants for on-demand treatment of new bleed.
A sum of all IV infusions of ReFacto AF received by the participants for on-demand treatment of new bleed.
Overall Number of Participants Analyzed 23 23 23
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
149 44 193
Measure Type: Number
Unit of Measure: Infusions
Excellent 51 7 58
Good 48 19 67
Moderate 28 12 40
No response 3 5 8
Data not recorded 19 1 20
4.Secondary Outcome
Title Total Number of Infusions Needed for Resolution of Bleeding Episodes Classified on Basis of Response to Study Drug Infusion
Hide Description Number of infusions of Refacto AF required for resolution of a bleeding episodes were classified on basis of the response at 4-point response scale of assessment (excellent, good, moderate and no response). Excellent: definite pain relief and/or improvement in bleeding signs within 8 hours (hr) after infusion, no additional infusion administered; Good: definite pain relief and/or improvement in bleeding signs within 8 hr after infusion, at least 1 additional infusion administered for complete resolution or with no additional infusion administered; Moderate: probable or slight improvement starting after 8 hr following infusion, at least 1 additional infusion administered for complete resolution; No Response: no improvement at all between infusions or during 24 hr interval following infusion or condition worsen. Bleeds for which response not recorded, reported as: Data Not Recorded.
Time Frame Within 48 hours after infusion, up to 2 years treatment duration
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title One IV Infusion Two IV Infusions Three IV Infusions Four IV Infusions Greater Than 4 IV Infusions Total Number of Bleeds
Hide Arm/Group Description:
One IV infusion of ReFacto AF received by the participants.
Two IV infusions of ReFacto AF received by the participants.
Three IV infusions of ReFacto AF received by the participants.
Four IV infusions of ReFacto AF received by the participants.
> 4 IV infusions of ReFacto AF received by the participants.
Total number of bleeds reported in the study.
Overall Number of Participants Analyzed 23 23 23 23 23 23
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
132 13 1 0 4 150
Measure Type: Number
Unit of Measure: Infusions
Excellent 48 3 0 0 51
Good 43 5 0 1 49
Moderate 22 4 0 2 28
No response 2 0 0 1 3
Data Not Recorded 17 1 1 0 19
5.Secondary Outcome
Title Total Number of Breakthrough Bleeding Episodes Occurring Within 48 Hours After a Prophylaxis Infusion of ReFacto AF
Hide Description The number of breakthrough bleeds (spontaneous or traumatic) within 48 hours following a prophylaxis dose of ReFacto AF are summarized. If there was more than 1 bleed location (like ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: Breakthrough Bleeds
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF and had a bleeding episode within 48 hours after a prophylaxis infusion of ReFacto AF.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: Bleeding episodes
12
6.Secondary Outcome
Title Consumption of Total International Units of Factor VIII
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: On Demand Overall Participants: Preventive Overall Participants: Prophylaxis Overall Participants: Setting Not Specified Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in on demand setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in preventive setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in unspecified setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 21 7 22 4 23
Mean (Standard Deviation)
Unit of Measure: International units
4186  (3038.4) 1857  (2357.5) 55543  (55535.5) 1634  (2523.8) 57799  (55125.8)
7.Secondary Outcome
Title Consumption of Total International Units of Factor VIII Per Year
Hide Description Consumption of total international units of Factor VIII per year was calculated for a participant: dividing the total consumption of factor VIII by participant’s treatment interval duration (in days), then multiplying by 365.25.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: International units per year
72336  (123407.9)
8.Secondary Outcome
Title Mean Dose (IU) of Study Drug Consumed Per Infusion
Hide Description Mean dose for each participant was calculated as participant’s total factor VIII consumption (in IU) divided by the number of infusions administered.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: On Demand Overall Participants: Preventive Overall Participants: Prophylaxis Overall Participants: Setting Not Specified Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in on demand setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in preventive setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in unspecified setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 21 7 22 4 23
Mean (Standard Deviation)
Unit of Measure: International units per infusion
552  (296.7) 544  (285.6) 628  (389.6) 481  (401.5) 619  (386.5)
9.Secondary Outcome
Title Consumption of Total International Units of Factor VIII by Weight
Hide Description Consumption of total international units of Factor VIII by weight was calculated for a participant: dividing the total consumption of factor VIII by participant’s weight (the most recently recorded).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: On Demand Overall Participants: Preventive Overall Participants: Prophylaxis Overall Participants: Setting Not Specified Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in on demand setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in preventive setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in unspecified setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 21 7 22 4 23
Mean (Standard Deviation)
Unit of Measure: International units per kilogram
388  (297.0) 93  (56.8) 4766  (4933.5) 187  (256.5) 4966  (4891.4)
10.Secondary Outcome
Title Consumption of Total International Units of Factor VIII Per Year by Weight
Hide Description Consumption of total international units of Factor VIII per year by weight was calculated for a participant: the total consumption of factor VIII divided by participant’s treatment interval duration (in days), then multiplying by 365.25 and then dividing by participant’s weight (the most recently recorded).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: International units per kilogram*years
6398  (11102.8)
11.Secondary Outcome
Title Mean Dose (IU) of Study Drug Consumed Per Infusion by Weight
Hide Description Mean dose for each participant was calculated as participant’s total factor consumption (in IU) divided by the number of infusions administered and then dividing by participant’s weight (the most recently recorded).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: On Demand Overall Participants: Preventive Overall Participants: Prophylaxis Overall Participants: Setting Not Specified Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in on demand setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in preventive setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in unspecified setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 21 7 22 4 23
Mean (Standard Deviation)
Unit of Measure: International units per kilogram
49  (26.1) 42  (16.9) 55  (34.4) 50  (41.0) 53  (33.5)
12.Secondary Outcome
Title Mean of Total Number of Infusions of Study Drug Received
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: On Demand Overall Participants: Preventive Overall Participants: Prophylaxis Overall Participants: Setting Not Specified Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in on demand setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in preventive setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in unspecified setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 21 7 22 4 23
Mean (Standard Deviation)
Unit of Measure: Infusions
9  (8.0) 5  (8.9) 80  (36.9) 2  (1.9) 86  (37.5)
13.Secondary Outcome
Title Mean of Total Number of Days Participants Exposed to Study Drug
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: On Demand Overall Participants: Preventive Overall Participants: Prophylaxis Overall Participants: Setting Not Specified Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in on demand setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in preventive setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF in unspecified setting.
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 21 7 22 4 23
Mean (Standard Deviation)
Unit of Measure: Days
8  (6.3) 3  (3.7) 76  (31.3) 2  (1.9) 81  (32.4)
14.Secondary Outcome
Title Number of Participants Who Required Dose Escalation of Their Prescribed Prophylaxis Regimen During Their Participation in This Study
Hide Description The number of participants who met the dose escalation criteria were prescribed a higher dose and/or were prescribed more frequent doses. When dose escalation was required, the specific dose and dosing schedule was at the investigator’s discretion.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set consisted of all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: Prophylaxis
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
15
  68.2%
15.Secondary Outcome
Title Percentage of Bleeding Episodes With Less-Than-Expected Therapeutic Effect (LETE) in On-Demand (OD) Setting
Hide Description LETE occurs in OD setting if participant recorded 2 successive “No Response” (no improvement at all between infusions, or condition worsens) ratings after 2 successive infusions of study drug. Infusions must have been given within 24 hours (hr) of each other for treatment of same bleeding event in absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of greater than (>) 4 hr between onset of bleed to infusion, delay of >24 hr before administration of a follow-up infusion, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator, ongoing trauma responsible for continued bleeding.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 23
Overall Number of Units Analyzed
Type of Units Analyzed: Bleeding episodes
150
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of bleeding episodes
0
(0.00 to 2.43)
16.Secondary Outcome
Title Percentage of Bleeding Episodes With Less-Than-Expected Therapeutic Effect (LETE) in the Prophylaxis Setting
Hide Description LETE in prophylaxis setting if there was a spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of study drug (which was not used to treat a bleed) in the absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose [a dose less than that prescribed in participant’s regimen], known lack of adherence to the prescribed prophylaxis regimen, known compromised study drug, faulty administration of study drug, participant had an underlying, predisposing condition responsible for the bleed in the opinion of the investigator, traumatic injury responsible for bleeding.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants: Prophylaxis
Hide Arm/Group Description:
All participants enrolled in the study who received at least 1 dose of ReFacto AF in prophylaxis setting.
Overall Number of Participants Analyzed 22
Overall Number of Units Analyzed
Type of Units Analyzed: Routine prophylaxis infusions
1752
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of bleeding episodes
0.11
(0.01 to 0.41)
17.Secondary Outcome
Title Total Number of Events of Potential Less-Than-Expected Therapeutic Effect (LETE) in the Low Recovery Setting
Hide Description LETE was lower than expected recovery of FVIII in the opinion of the investigator following infusion of study drug in the absence of confounding factors (known presence or subsequent identification of a FVIII inhibitor, known compromised study drug, faulty administration of study drug including inadequate dosing).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set consisted of all participants who had received at least 1 dose of ReFacto AF.
Arm/Group Title Overall Participants
Hide Arm/Group Description:
All participants who received at least 1 dose of ReFacto AF.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Events
10
Time Frame Through study completion up to 2 years
Adverse Event Reporting Description Event may be serious in 1 and non serious in other participant or 1 participant may have experienced both serious and non serious adverse event.
 
Arm/Group Title Overall Participants
Hide Arm/Group Description All participants enrolled in the study who had received at least 1 dose of ReFacto AF.
All-Cause Mortality
Overall Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Overall Participants
Affected / at Risk (%) # Events
Total   11/23 (47.83%)    
Blood and lymphatic system disorders   
Factor VIII inhibition * 1  8/23 (34.78%)  8
Gastrointestinal disorders   
Ileus * 1  1/23 (4.35%)  1
Intussusception * 1  1/23 (4.35%)  1
Immune system disorders   
Milk allergy * 1  1/23 (4.35%)  1
Infections and infestations   
Appendicitis * 1  1/23 (4.35%)  1
Enterobacter sepsis * 1  1/23 (4.35%)  1
Gastroenteritis * 1  1/23 (4.35%)  1
Sepsis * 1  1/23 (4.35%)  1
Upper respiratory tract infection * 1  1/23 (4.35%)  1
Injury, poisoning and procedural complications   
Contusion * 1  1/23 (4.35%)  1
Fall * 1  1/23 (4.35%)  1
Road traffic accident * 1  1/23 (4.35%)  1
Tongue injury * 1  1/23 (4.35%)  1
Nervous system disorders   
Febrile convulsion * 1  1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Participants
Affected / at Risk (%) # Events
Total   20/23 (86.96%)    
Blood and lymphatic system disorders   
Anaemia * 1  5/23 (21.74%)  5
Ear and labyrinth disorders   
Ear pain * 1  2/23 (8.70%)  2
Gastrointestinal disorders   
Mouth haemorrhage * 1  4/23 (17.39%)  4
Diarrhoea * 1  3/23 (13.04%)  3
Vomiting * 1  3/23 (13.04%)  3
Teething * 1  2/23 (8.70%)  3
General disorders   
Pyrexia * 1  10/23 (43.48%)  13
Immune system disorders   
Hypersensitivity * 1  2/23 (8.70%)  2
Infections and infestations   
Gastroenteritis * 1  6/23 (26.09%)  7
Nasopharyngitis * 1  6/23 (26.09%)  14
Bronchitis * 1  3/23 (13.04%)  5
Upper respiratory tract infection * 1  3/23 (13.04%)  4
Conjunctivitis * 1  2/23 (8.70%)  2
Influenza * 1  2/23 (8.70%)  2
Pharyngitis * 1  2/23 (8.70%)  3
Rhinitis * 1  2/23 (8.70%)  2
Injury, poisoning and procedural complications   
Fall * 1  4/23 (17.39%)  8
Head injury * 1  2/23 (8.70%)  3
Lip injury * 1  2/23 (8.70%)  2
Procedural pain * 1  2/23 (8.70%)  2
Musculoskeletal and connective tissue disorders   
Haemarthrosis * 1  3/23 (13.04%)  5
Respiratory, thoracic and mediastinal disorders   
Cough * 1  4/23 (17.39%)  7
Skin and subcutaneous tissue disorders   
Eczema * 1  2/23 (8.70%)  2
Rash * 1  2/23 (8.70%)  2
Vascular disorders   
Haematoma * 1  4/23 (17.39%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator may publish or otherwise publicly communicate the results, subject to the provisions of the Clinical Study Agreement.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00950170     History of Changes
Other Study ID Numbers: 3082B2-4434
B1831006 ( Other Identifier: Alias Study Number )
2008-008436-93 ( EudraCT Number )
First Submitted: July 29, 2009
First Posted: July 31, 2009
Results First Submitted: May 23, 2017
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019