In the article ‘Safety and tolerability of 5-grass pollen tablet sublingual immunotherapy: pooled analysis and clinical review’ published in the May 2015 issue of Expert Opinion on Drug Safety (Expert Opinion on Drug Safety May 2015, Vol. 14, No. 5: 777-788) a number of errors have been identified following publication.
In Table 1, the third column outlining the population for study VO56.07A and study VO60.08.
‘Patients with grass pollen-related ARC without asthma’
Should read:
‘Patients with grass pollen-related ARC with or without mild asthma’
In section 3.3.2, Time to onset of TEAEs, the first sentence of the second paragraph ‘Of the 5.1% of patients who discontinued treatment because of TEAEs, 31.2 and 68.8% did so within the first week or first month, respectively, following commencement of therapy’.
Should read:
‘Of the 5.1% of actively treated patients who discontinued treatment because of TEAEs, 31.2 and 68.8% did so within the first week or first month, respectively, following commencement of therapy’.
In Figure 2, the legend: ‘Time to onset of most frequently reported treatment-emergent adverse events leading to premature study discontinuation in patients treated with the 5 grass pollen tablet’.
Should read:
‘Time to onset of most frequently reported treatment-emergent adverse events in patients treated with the 5-grass pollen tablet’.
Table 5, the legend ‘TEAEs occurring in the safety population (n = 2512), stratified by sensitization and asthma status’.
Should include an asterisk and comment as below:
‘TEAEs occurring in the safety population (n = 2512), stratified by sensitization* and asthma status’.
*Data was missing for one patient.