Table 2 Summary of Prior Home Infusion in Enrolled Patients Who Started the Homecare Setting Before Enrollment
Cohort A (N = 29) | Cohort B (N = 6) | Total (N = 35) | |
|---|---|---|---|
Number of dilutions performed by patients | |||
Mean (SD) | 1.0 (0.00) | 1.0 (0.00) | 1.0 (0.00) |
Q1; Q3 | 1.0; 1.0 | 1.0; 1.0 | 1.0; 1.0 |
Range | 1; 1 | 1; 1 | 1; 1 |
Any change in dilution infusion, n (%) | |||
Yes | 0 | 0 | 0 |
No | 29 (100.00) | 6 (100.00) | 35 (100.00) |
Prior home infusion by rate of administration, n (%) | |||
Every 2 weeks | 27 (93.10) | 0 | 27 (77.14) |
Weekly | 2 (6.90) | 6 (100.00) | 8 (22.86) |
Infusions by administration of any pre-medication, n (%) | |||
No | 22 (75.86) | 3 (50.00) | 25 (71.43) |
Yes | 7 (24.14) | 3 (50.00) | 10 (28.57) |
Number of missed ERT infusions during ERT administration in a homecare setting | |||
Mean (SD) | 0.7 (1.26) | 3.8 (6.40) | 1.2 (2.96) |
Q1; Q3 | 0.0; 1.0 | 0.0; 6.0 | 0.0; 1.0 |
Range | 0; 4 | 0; 16 | 0; 16 |
Average duration of infusion (hours) a | |||
Mean (SD) | 4.7 (1.16) | 3.7 (0.52) | 4.5 (1.15) |
Q1; Q3 | 4.0; 6.0 | 3.0; 4.0 | 4.0; 5.0 |
Range | 3; 7 | 3; 4 | 3; 7 |
Prior Adverse Drug Reactions (ADRs) n (%) b | |||
Number of prior ADRs | 3 | 3 | 6 |
Number of prior ADRs by setting | |||
Home infusion | 0 | 2 (66.67) | 2 (33.33) |
Hospital infusion | 3 (100.00) | 1 (33.33) | 4 (66.67) |
Serious prior ADRs | |||
No | 1 (33.33) | 3 (100.00) | 4 (66.67) |
Yes | 2 (66.67) | 0 | 2 (33.33) |
Intensity of prior ADRs | |||
Mild | 1 (33.33) | 3 (100.00) | 4 (66.67) |
Moderate | 2 (66.67) | 0 | 2 (33.33) |
MedDRA System organ class/ Preferred term c | |||
General disorders and administration site conditions | 0 | 1 (16.67) | 1 (2.86) |
Pyrexia | 0 | 1 (16.67) | 1 (2.86) |
Immune system disorders | 1 (3.45) | 0 | 1 (2.86) |
Urticaria | 1 (3.45) | 0 | 1 (2.86) |
Respiratory, thoracic, and mediastinal disorders | 1 (3.45) | 0 | 1 (2.86) |
Dyspnea | 1 (3.45) | 0 | 1 (2.86) |
Skin and subcutaneous tissue disorders | 1 (3.45) | 1 (16.67) | 2 (5.71) |