Adherence to PTH(1-84) Treatment (FP-002-IM)

A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as "temporarily discontinued" if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still "ongoing" during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as "missing" or "unknown" if they attended the relevant visit and there was no result or "unknown" was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.

Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.

A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to. Data on compliance were obtained at each visit and relate to the period since the previous recorded visit.