Table 4.
Primary reasons for study discontinuation (safety set)
| Total (n = 172) | Patients |
|
|---|---|---|
| n | % | |
| Patient reached adult height/bone age maturationa | 52 | 30.2 |
| Reached near adult heighta | 28 | 16.3 |
| Patient satisfied with current height | 5 | 2.9 |
| Lost to follow-up | 15 | 8.7 |
| Adverse event | 10 | 5.8 |
| Patient does not wish to continue the injections | 9 | 5.2 |
| Site closure | 9 | 5.2 |
| Switch to other GH medicine | 9 | 5.2 |
| No treatment responseb | 6 | 3.5 |
| Patient noncompliant | 3 | 1.7 |
| HV slowdown (HV <1 cm/year) | 2 | 1.2 |
| Referral to adult endocrinologist | 1 | 0.6 |
| Withdrawal of informed consent | 1 | 0.6 |
| Others | 22 | 12.7 |
GH, growth hormone; HV, height velocity; SDS, standard deviation score.
a
According to physician assessment.
b
No treatment response defined as HVSDS <1 after first year of treatment; HV <2 cm/year postbaseline. If confirmation is required, bone age is >14 years for girls or >16 years for boys, corresponding to closure of epiphyseal growth plate (postbaseline).