Table 1.
Patient disposition and demographics
Parameter | Measure |
---|---|
Number of patients treated | 33 |
Number of patients not completing study, n (%) | 10 (30) |
Principal reason for withdrawal, n (%) | |
Adverse events | 1 (3) |
Uncooperative (could not make visits) | 1 (3) |
Wishes to withdraw | 3 (9) |
Sponsor ended study | 3 (9) |
Others (lung cancer and circumstances prevented further participation) | 2 (6) |
Study treatment duration, months, median (range) | 49.4 (4.2–58.6) |
Time of last efficacy visit, n (%) | |
≤12 months | 6 (18) |
>12 to ≤24 months | 0 |
>24 to ≤36 months | 4 (12) |
>36 to 48 months | 23 (70) |
Gender, n (%) | |
Male | 19 (58) |
Female | 14 (42) |
Ethnicity, n (%) | |
Ashkenazi Jewish | 23 (70) |
Non-Jewish Caucasian | 6 (18) |
African-American/Caribbean | 1 (3) |
Hispanic | 2 (6) |
American Indian | 1 (3) |
Others | 2 (6) |
Genotype, n (%) | |
N370S N370S | 22 (67) |
N370S-L444P | 6 (18) |
N370S-D409H | 1 (3) |
N370S-IVS2+1 | 1 (3) |
N370S-unknown | 2 (6) |
Unknown | 1 (3) |
Patients with total splenectomy, n (%) | 5 (15) |
Median age at Gaucher symptom onset, years (range) | 32.0 (11.0–52.0) |
Median age at consent, years (range) | 43.0 (12.0–70.0) |
Median weight at baseline, kg (range) | 64.2 (34.0–105.0) |
Median height at baseline, cm (range) | 169.9 (146.5–190.5) |