Erratum to: Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial (Headache: The Journal of Head and Face Pain, (2020), 60, 1, (141-152), 10.1111/head.13682)

Authors
Category Primary study
JournalHeadache
Year 2021
Ailani, J., Lipton, R.B., Hutchinson, S., Knievel, K., Lu, K., Butler, M., Yu, S.Y., Finnegan, M., Severt, L., and Trugman, J.M. (2020), Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52-Week Extension Trial. Headache: The Journal of Head and Face Pain, 60: 141-152 The authors of the above-referenced article have self-reported several errors in their paper. Please note Tables 2 and 3 and Figure 1 have been corrected as a result and reproduced here. 2 TABLE Common (≥2%)a treatment-emergent adverse events by preferred term (Table presented.) a Only adverse events reported in ≥2% of participants (after rounding) in any treatment group are shown (includes usual care group; data are not shown). Participants are counted only once within each preferred term. b Preferred terms were coded according to the Medical Dictionary of Regulato2ry Activity (MedDRA) Version 20.1. c For sex-specific adverse events, percentages are relative to the number of participants of the appropriate sex. 3 TABLE Treatment-emergent cardiovascular adverse events of special interest (Table presented.) Abbreviations: CNS, central nervous system; TEAE, treatment-emergent adverse event. a Each category is based on pre-defined standard groups of Preferred Terms (narrow Standard MedDRA Queries). b Reported as a serious adverse event. c The participant with hemiparesis had negative imaging for any vascular events and stroke was ruled out as a possible cause. The investigator attributed the event to severe uncontrolled hypothyroidism. In addition, the following sentences within the text require correcting: Severe TEAEs that were reported for 3 or more participants in the ubrogepant groups were AST increase, cholelithiasis, nephrolithiasis, pneumonia, and sinusitis (each reported for 3 ubrogepanttreated participants); influenza, migraine, and nausea were each reported for 4 ubrogepant-treated participants. This sentence should now read as follows: Severe TEAEs that were reported for 3 or more participants in the ubrogepant groups were AST increase, cholelithiasis, nephrolithiasis, and pneumonia (each reported for 3 ubrogepant-treated participants); influenza, migraine, sinusitis and nausea were each reported for 4 ubrogepant-treated participants. Twenty cases of ALT or AST elevations of ≥3× ULN were reported, as follows: 4/398 (1.0%) in the usual care arm, 5/399 (1.3%) in the ubrogepant 50 mg arm, and 11/406 (2.7%) in the ubrogepant 100 mg arm. This sentence should now read as follows: Twenty cases of ALT or AST elevations of ≥3× ULN were reported, as follows: 4/397 (1.0%) in the usual care arm, 5/399 (1.3%) in the ubrogepant 50 mg arm, and 11/406 (2.7%) in the ubrogepant 100 mg arm. (Figure presented.)
Epistemonikos ID: b35bc00afe62a8c4d3c74b72c884f09bd1fd9d39
First added on: Dec 06, 2024