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. 2023 Oct 26;41(1):198–214. doi: 10.1007/s12325-023-02705-9

Table 2.

Vosoritide follow-up protocol from the French Early Access Program [39]

Data elements of interest Day 0 visit
(Treatment start)
Teleconsultation
(Month 1)
Month 3 Month 6 and every 6 months End of follow-up
Documentation of achondroplasia
Demographics
Medical and surgical history
Clinical exam
Vital signs including blood pressure

Detailed anthropometric and

morphological measurements

√ (annual)
X-ray of left hand and one knee √ (annual)
Tanner stages √ (annual)

Medical and surgical events

(incl. ACH-related interventions or investigations including blood test results)

Administration, prescribing and adherence information for vosoritide
Visits healthcare professional
Adverse event collection
Concomitant and new medications

ACH achondroplasia