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 |