Table 4.

Reasons for patient-reported outcomes label claims exclusion identified in European public assessment reports reviewers ' comments (n = 76).

Comments from EMA reviewers	Number of indications n (%)
Study conduct
Data should be interpreted with caution as there was no blinding of the study treatment	1 (1.3%)
Potential bias in PRO data as a result of blinding failure	2 (2.6%)
Interpretability of QoL results and therefore their clinical relevance is unclear/limited	8 (6.6%)
Rational for timing and frequency of PRO collection was not fully described with regard to population, disease and/or treatment regimen	4 (5.3%)
PRO analysis was not robust enough or did not even exist	4 (5.3%)
PRO analysis was considered exploratory	4 (5.3%)
PROM selection
PROM selected was not considered optimal	4 (5.3%)
Missing data
Handling missing data was not included and/or sufficient	2 (2.6%)
Reliability of the results was hampered due to missing data	5 (6.6%)
Study design
Value of data was questionable and caution in interpretation is needed when using open-label design	16 (21.1%)
No firm conclusion could be drawn from the QoL data of single arm trials	2 (2.6%)