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Table 3 Summary and analysis of likely cardiovascular treatment-emergent adverse events

From: Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials

Standardized MedDRA Query
Preferred Term
Placebo
(N = 1262)
All LTN
(N = 3177)
Comparison between all LTN vs. placebo
n (%) [adj %] n (%) [adj %] ORa 95% CIa p valueb
Patients with at least 1 likely CV TEAE 5 (0.4) [0.4] 30 (0.9) [0.9] 2.46 (0.95, 6.39) 0.06
 Cardiac arrhythmias (SMQ) 3 (0.2) [0.2] 27 (0.8) [0.9] 3.59 (1.09, 11.79) 0.02
  Palpitations 1 (0.1) [0.1] 12 (0.4) [0.4] 4.67 (0.63, 34.69) 0.09
  Tachycardia 0 (0.0) [0.0] 6 (0.2) [0.2]    0.14
  Heart rate increased 1 (0.1) [0.1] 5 (0.2) [0.2] 1.89 (0.23, 15.65) 0.54
  Bradycardia 1 (0.1) [0.1] 1 (0.0) [0.0] 0.50   0.62
  Electrocardiogram abnormal 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
  Sinus bradycardia 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
  Syncope 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Cardiomyopathy (SMQ) 1 (0.1) [0.1] 14 (0.4) [0.4] 5.45 (0.74, 40.05) 0.06
  Palpitations 1 (0.1) [0.1] 12 (0.4) [0.4] 4.67 (0.63, 34.69) 0.09
  Electrocardiogram abnormal 0 (0.0) [0.0] 1 (0.0) [0.0]    0.48
  Syncope 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Hypertension (SMQ) 0 (0.0) [0.0] 3 (0.1) [0.1]    0.28
  Hypertension 0 (0.0) [0.0] 2 (0.1) [0.1]    0.36
  Blood pressure increased 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Pulmonary hypertension (SMQ) 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
  Cardiac murmur 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
 Torsade de pointes/QT prolongation (SMQ) 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
  Syncope 0 (0.0) [0.0] 1 (0.0) [0.0]    0.56
 Any abdominal pain (PT) 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
  Abdominal pain upper 1 (0.1) [0.1] 0 (0.0) [0.0] 0.00   0.16
  1. aMantel-Haenszel OR stratified by study and 95% CI (CI calculated if ≥4 events in numerator and ≥ 1 event in denominator)
  2. bp values are from Cochran-Mantel-Haenszel test of general association stratified by study. Bold indicates a p value < 0.05
  3. adj % study size adjusted percentage, CI Confidence interval, CNS Central nervous system, CV Cardiovascular, LTN Lasmiditan, MedDRA Medical Dictionary for Drug Regulatory Activities, N Number of patients in the analysis population, n number of patients within each specific category, OR Odds ratio, PT Preferred Term, SMQ Standardized MedDRA Query, TEAE treatment-emergent adverse event
  4. Likely CV TEAEs are from medical review out of potential CV TEAEs that are selected based on broad and narrow terms in the SMQs Cardiac arrhythmias, Cardiac failure, Cardiomyopathy, CNS vascular disorders, Embolic and thrombotic events, Hypertension, Ischemic heart disease, Pulmonary hypertension, and Torsade de pointes/QT prolongation and the PTs abdominal pain, abdominal pain upper, and abdominal pain lower
  5. Any abdominal pain (PT) consists of the PTs abdominal pain, abdominal pain upper, and abdominal pain lower
  6. MedDRA version 21.0