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.
TABLE 2.
Common (≥2%)a treatment‐emergent adverse events by preferred term
| Preferred termb | Ubrogepant 50 mg | Ubrogepant 100 mg |
|---|---|---|
| n = 404 | n = 409 | |
| n (%) | n (%) | |
| Nasopharyngitis | 33 (8.2) | 47 (11.5) |
| Upper respiratory tract infection | 47 (11.6) | 44 (10.8) |
| Sinusitis | 28 (6.9) | 26 (6.4) |
| Urinary tract infection | 22 (5.4) | 26 (6.4) |
| Influenza | 17 (4.2) | 25 (6.1) |
| Nausea | 19 (4.7) | 19 (4.6) |
| Bronchitis | 13 (3.2) | 18 (4.4) |
| Blood creatine phosphokinase increased | 10 (2.5) | 16 (3.9) |
| Alanine aminotransferase increased | 9 (2.2) | 15 (3.7) |
| Aspartate aminotransferase increased | 7 (1.7) | 14 (3.4) |
| Back pain | 14 (3.5) | 14 (3.4) |
| Nephrolithiasis | 4 (1.0) | 13 (3.2) |
| Dizziness | 5 (1.2) | 12 (2.9) |
| Anxiety | 6 (1.5) | 11 (2.7) |
| Cough | 8 (2.0) | 11 (2.7) |
| Diarrhea | 10 (2.5) | 11 (2.7) |
| Muscle strain | 5 (1.2) | 11 (2.7) |
| Arthralgia | 11 (2.7) | 10 (2.4) |
| Gastroenteritis viral | 7 (1.7) | 10 (2.4) |
| Seasonal allergy | 2 (0.5) | 10 (2.4) |
| Vomiting | 8 (2.0) | 9 (2.2) |
| Hypertension | 8 (2.0) | 7 (1.7) |
| Depression | 1 (0.2) | 5 (1.2) |
| Migraine | 6 (1.5) | 4 (1.0) |
| Abdominal pain | 4 (1.0) | 2 (0.5) |
| Epididymitisc | 1 (3.2) | 0 (0) |
| Testicular painc | 1 (3.2) | 0 (0) |
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.
Preferred terms were coded according to the Medical Dictionary of Regulato2ry Activity (MedDRA) Version 20.1.
For sex‐specific adverse events, percentages are relative to the number of participants of the appropriate sex.
TABLE 3.
Treatment‐emergent cardiovascular adverse events of special interest
| TEAE categorya | Ubrogepant 50 mg | Ubrogepant 100 mg |
|---|---|---|
| Preferred term | n = 404 | n = 409 |
| n (%) | n (%) | |
| Cardiac arrhythmias | 4 (1.0) | 5 (1.2) |
| Arrhythmia | 0 | 1 (0.2) |
| ECG QRS complex prolonged | 0 | 1 (0.2) |
| Extrasystoles | 0 | 1 (0.2) |
| Sinus tachycardiab | 1 (0.2) | 1 (0.2) |
| Ventricular extrasystoles | 0 | 1 (0.2) |
| Atrioventricular block first degree | 1 (0.2) | 0 |
| Cardiac flutter | 1 (0.2) | 0 |
| Sinus bradycardia | 1 (0.2) | 0 |
| CNS vascular disorder/embolic and thrombotic events | 0 | 2 (0.5) |
| Hemiparesis a , c | 0 | 1 (0.2) |
| Traumatic subdural hematomab | 0 | 1 (0.2) |
| Hypertension | 13 (3.2) | 11 (2.7) |
| Hypertension | 8 (2.0) | 7 (1.7) |
| Blood pressure diastolic increased | 1 (0.2) | 2 (0.5) |
| Blood pressure increased | 3 (0.7) | 2 (0.5) |
| Hypertensive crisisb | 1 (0.2) | 0 |
| Prehypertension | 1 (0.2) | 0 |
| Ischemic heart disease | 2 (0.5) | 2 (0.5) |
| Angina pectoris | 2 (0.5) | 2 (0.5) |
Abbreviations: CNS, central nervous system; TEAE, treatment‐emergent adverse event.
Each category is based on pre‐defined standard groups of Preferred Terms (narrow Standard MedDRA Queries).
Reported as a serious adverse event.
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.
