SUPPLEMENTAL MATERIAL

Table A. Quality of Life Questionnaires for Adults (SF-36) and Children (CHQ-PF50) at Baseline, Month 6 and Month 12: PP Population

Scale, mean ± SD / Baseline / Month 6 / Month 12 / Baseline to Month 6 / Baseline to Month 12
Change / p-value / Change / p-value
SF-36 / N = 26 / N = 27 / N = 26 / N = 26 / N = 25
Physical functioning / 73.7 ± 27.11 / 77.2 ± 27.92 / 74.8 ± 29.00 / 2.7 ± 7.65 / 0.070 / 3.8 ± 11.02 / 0.134
Role-physical / 65.1 ± 29.11 / 71.8 ± 31.36 / 69.5 ± 31.29 / 5.5 ± 22.52 / 0.222 / 3.0 ± 24.75 / 0.550
Bodily pain / 61.4 ± 28.01 / 65.0 ± 28.05 / 70.6 ± 23.35 / 2.3 ± 21.73 / 0.648 / 9.2 ± 27.57 / 0.110
General health perceptions / 43.7 ± 25.90 / 53.0 ± 27.82 / 52.0 ± 24.22 / 9.0 ± 17.54 / 0.015* / 7.3 ± 17.36 / 0.047*
Vitality / 51.0 ± 21.56 / 60.0 ± 22.22 / 58.4 ± 15.90 / 8.2 ± 16.66 / 0.019* / 7.3 ± 19.66 / 0.078
Social functioning / 74.0 ± 27.14 / 75.9 ± 27.72 / 76.9 ± 26.62 / 1.0 ± 24.98 / 0.846 / 1.5 ± 24.82 / 0.776
Role-emotional / 86.5 ± 22.12 / 88.9 ± 24.35 / 82.1 ± 25.02 / 1.9 ± 19.76 / 0.914 / -5.7 ± 18.75 / 0.199
Mental health / 73.5 ± 17.71 / 82.8 ± 17.45 / 80.2 ± 12.77 / 8.7 ± 15.46 / 0.006* / 5.2 ± 15.38 / 0.104
Physical summary / 41.5 ± 12.95 / 43.4 ± 12.44 / 44.2 ± 12.45 / 1.5 ± 6.06 / 0.114 / 3.2 ± 9.49 / 0.110
Mental summary / 49.7 ± 9.36 / 53.1 ± 9.89 / 51.1 ± 9.47 / 3.1 ± 9.14 / 0.092 / 0.4 ± 9.23 / 0.250
CHQ-PF50 / N = 5 / N = 5 / N = 5 / N = 5 / N = 5
Physical functioning / 100 ± 0.00 / 100 ± 0.00 / 100 ± 0.00 / 0.00 ± 0.00 / - / 0.00 ± 0.00 / N/A
Role/social functioning – emotion/behavioral / 97.2 ± 5.56 / 77.8 ± 38.49 / 100 ± 0.00 / -18.5 ± 42.07 / 0.525 / 3.7 ± 6.42 / 0.999
Role/social functioning – physical / 100 ± 0.00 / 100 ± 0.00 / 100 ± 0.00 / 0.00 ± 0.00 / - / 0.00 ± 0.00 / N/A
Bodily pain / 84.0 ± 15.17 / 70.0 ± 16.33 / 85.0 ± 17.32 / -15.0 ± 12.91 / 0.103 / 0.00 ± 24.49 / 0.999
Behavior / 79.0 ± 9.38 / 71.9 ± 14.69 / 69.4 ± 14.58 / -3.5 ± 9.09 / 0.493 / -6.0 ± 10.77 / 0.343
Mental health / 82.0 ± 6.71 / 71.3 ± 20.97 / 75.0 ± 14.72 / -10.0 ± 17.80 / 0.343 / -6.3 ± 11.81 / 0.368
Self-esteem / 93.5 ± 7.76 / 80.4 ± 5.20 / 85.4 ± 14.23 / -12.5 ± 10.76 / 0.103 / -7.5 ± 20.98 / 0.526
General health / 41.7 ± 19.78 / 46.0 ± 22.34 / 52.7 ± 24.15 / 8.5 ± 11.9 / 0.224 / 15.2 ± 8.51 / 0.037*
Parental impact – emotional / 70.0 ± 30.39 / 45.8 ± 41.11 / 62.5 ± 32.27 / -20.8 ± 20.97 / 0.141 / -4.2 ± 15.96 / 0.638
Parental impact – time / 82.2 ± 27.89 / 77.8 ± 20.29 / 91.7 ± 16.67 / 0.0 ± 27.22 / 0.999 / 13.9 ± 13.98 / 0.141
Family activities / 77.5 ± 24.04 / 77.1 ± 17.51 / 85.4 ± 18.48 / 3.1 ± 12.44 / 0.650 / 11.5 ± 8.9 / 0.076
Physical summary / 48.1 ± 2.76 / 47.7 ± 4.21 / 52.3 ± 3.55 / 0.4 ± 1.51 / 0.685 / 3.4 ± 2.87 / 0.180
Psycho-social summary / 53.5 ± 5.32 / 41.5 ± 13.93 / 50.0 ± 9.08 / -9.9 ± 10.14 / 0.232 / -5.1 ± 2.48 / 0.070
SF-36 and CHQ-PF50 Composites / N = 30 / N = 30 / N = 30 / N = 29 / N = 28
Physical Composite / 42.4 ± 12.27 / 43.8 ± 11.90 / 45.3 ± 11.90 / 1.4 ± 5.75 / 0.208 / 3.2 ± 8.98 / 0.072
Mental Composite / 50.2 ± 8.92 / 52.0 ± 10.66 / 51.0 ± 9.27 / 1.8 ± 9.92 / 0.594 / -0.2 ± 8.90 / 0.594
Note: scores ranged for all scales from 0 (worst) to 100 (best). Physical, mental and psycho-social summaries and composites were normalized based on US population averages and standard deviations (SD).
* Statistically significant for comparison of 12-month scores with baseline scores; N/A = not applicable; p-values were generated using paired t-test if the change was approximately normally distributed or Wilcoxon signed rank test, otherwise.

Table B. Incidence (2 or more patients) of Treatment-Emergent Adverse Events by Preferred Term and Relationship to Study Product: FAS Population

Relationship to Study Product - Total Counts [3]
Preferred Term / Number of Patients with Adverse Events [1] / Number of Adverse Events [2] / Not Related / Unlikely / Possibly / Probably / Definitely
Administration site reaction / 42 (82.4) / 1156 / 5 / 4 / 57 / 166 / 924
Upper respiratory tract infection / 18 (35.3) / 24 / 19 / 3 / 1 / 1 / 0
Sinusitis / 14 (27.5) / 32 / 25 / 7 / 0 / 0 / 0
Acute sinusitis / 7 (13.7) / 9 / 7 / 2 / 0 / 0 / 0
Bronchitis / 7 (13.7) / 10 / 8 / 2 / 0 / 0 / 0
Viral infection / 7 (13.7) / 10 / 10 / 0 / 0 / 0 / 0
Headache / 7 (13.7) / 16 / 2 / 0 / 7 / 7 / 0
Diarrhoea / 6 (11.8) / 7 / 6 / 0 / 1 / 0 / 0
Fatigue / 6 (11.8) / 6 / 2 / 0 / 3 / 0 / 1
Pyrexia / 5 (9.8) / 7 / 7 / 0 / 0 / 0 / 0
Otitis media / 5 (9.8) / 5 / 5 / 0 / 0 / 0 / 0
Gastrooesophageal reflux disease / 4 (7.8) / 4 / 3 / 1 / 0 / 0 / 0
Gastroenteritis viral / 4 (7.8) / 4 / 3 / 1 / 0 / 0 / 0
Oral herpes / 4 (7.8) / 6 / 6 / 0 / 0 / 0 / 0
Urinary tract infection / 4 (7.8) / 6 / 4 / 2 / 0 / 0 / 0
Migraine / 4 (7.8) / 5 / 4 / 0 / 0 / 1 / 0
Epistaxis / 4 (7.8) / 4 / 4 / 0 / 0 / 0 / 0
Nausea / 3 (5.9) / 4 / 0 / 1 / 2 / 1 / 0
Chronic sinusitis / 3 (5.9) / 5 / 5 / 0 / 0 / 0 / 0
Gastroenteritis / 3 (5.9) / 4 / 3 / 0 / 1 / 0 / 0
Influenza / 3 (5.9) / 4 / 4 / 0 / 0 / 0 / 0
Nasopharyngitis / 3 (5.9) / 3 / 3 / 0 / 0 / 0 / 0
Asthma / 3 (5.9) / 3 / 3 / 0 / 0 / 0 / 0
Dermatitis contact / 3 (5.9) / 3 / 3 / 0 / 0 / 0 / 0
Hypertension / 3 (5.9) / 3 / 3 / 0 / 0 / 0 / 0
Influenza like illness / 2 (3.9) / 2 / 2 / 0 / 0 / 0 / 0
Vomiting / 2 (3.9) / 2 / 1 / 0 / 1 / 0 / 0
Infusion related reaction / 2 (3.9) / 2 / 1 / 0 / 1 / 0 / 0
Pharyngitis streptococcal / 2 (3.9) / 2 / 2 / 0 / 0 / 0 / 0
Pneumonia / 2 (3.9) / 2 / 1 / 1 / 0 / 0 / 0
Pneumonia bacterial / 2 (3.9) / 2 / 1 / 0 / 1 / 0 / 0
Rhinitis / 2 (3.9) / 2 / 1 / 1 / 0 / 0 / 0
Fall / 2 (3.9) / 2 / 2 / 0 / 0 / 0 / 0
Neck pain / 2 (3.9) / 2 / 2 / 0 / 0 / 0 / 0
Haematuria / 2 (3.9) / 2 / 1 / 1 / 0 / 0 / 0
Oropharyngeal pain / 2 (3.9) / 2 / 2 / 0 / 0 / 0 / 0
Rhinitis / 2 (3.9) / 4 / 4 / 0 / 0 / 0 / 0
Wheezing / 2 (3.9) / 3 / 1 / 0 / 0 / 0 / 2
Rash / 2 (3.9) / 2 / 0 / 1 / 0 / 1 / 0
[1] Denominator used to calculate percentages: (N=51); [3] If a patient experiences the same event more than once, the occurrence of greatest relationship to study product is tabulated.
[2] May include more than one adverse event per patient.
[3] All occurrences tabulated.

VIRTUE Manuscript03 March 2010

Southern Medical JournalPage 1 of 5

Table C. Vivaglobin® Investigators

Stuart Abramson, MD, PhDTexas Children's Hospital - Allergy and Immunology Clinic, HoustonTX

Anne Suresh, MDAsthma, Allergy and ImmunologyCenter, FlintMI

James Baldwin, MDUniversity of Michigan Health Systems, Ann ArborMI

Paul Carter, MDThe Allergy, Asthma and SinusCenter, KnoxvilleTN

Joseph A. Church, MDChildren's Hospital - Los Angeles, Division of Clinical Immunology and Allergy, Los Angeles, CA

Timothy Craig, MDPennStateMiltonHersheyMedicalCenter, Hershey, PA

Jeffrey Demain, MDAllergy, Asthma and Immunology of Alaska, Anchorage, AK

Alan P. Knutsen, MDCardinal Glennon Children's MedicalCenter, St Louis, MO

Lisa J. Kobyrnski, MD, MPHEmoryUniversity - Division of Allergy and Immunology, Atlanta, GA

Harry A. Lee, MDAllergy, Asthma and Immunology of Montgomery, Montgomery, AL

A. Wesley Burks, MDDukeUniversityMedicalCenter - Department of Pediatrics, Durham, NC

Stephen Miles, MDAllSeasonsAllergyCenter, The Woodlands, TX

Lois A. Nelson, MDAsthma, Allergy and Immunology,Toledo, OH

Ralph Shapiro, MDMidwest Immunology Clinic, Plymouth, MN

John Sleasman, MDUniversity of South Florida - All Children's Hosptial

RicardoU.Sorensen, MDLSUHealthScienceCenter - New Orleans, LA

Mark Stein, MDAllergy Associates of the PalmBeaches, P.A., North Palm Beach, FL

S. Bobo Tanner, MDVanderbiltUniversitySchool of Medicine - Asthma, Sinus and Allergy Program, Nashville, TN

Michael A. Volz, MDAdvanced Allergy, Asthma & Immunology, Broomfield, CO

Firas A. Koura, MDKentucky Lung Clinic, Hazard, KY

Jonathan Matz, MDChesapeake Clinic Research, Inc., Baltimore, MD

Brian A. Smart, MDDupage Medical Group - Asthma and AllergyCenter, Glen Ellyn, IL

William A. McCann, MDAllergy Partners of Western North Carolina, Asheville, NC

Luis A. Matos, MDAsthma and AllergyCenter, Roanoke, VA

Tina W. Merritt, MDAllergy and Asthma Clinic of Northwest Arkansas, Bentonville, AR

Syed M. Rehman, MDAsthma and AllergyCenter, Toledo, OH

VIRTUE Manuscript03 March 2010

Southern Medical JournalPage 1 of 5