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Table 5 Treatment-emergent adverse events likely to be cardiovascular in nature

From: Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials

 Hypertension (SMQ)aEmbolic and Thrombotic events (SMQ)aIschemic heart disease (SMQ)a
Dose GroupAge Group (years)Nn/TPYEAIR (95% CI)n/TPYEAIR (95% CI)n/TPYEAIR (95% CI)
Double-blind treatment phase
Phase 3_Pooled
Placebo
< 42
42 to < 50
50 to < 60
60 to ≤ 65
687
359
309
96
6/248.3
7/134.9
3/112.8
2/33.5
2.4 (0.9, 5.3)
5.2 (2.1, 10.7)
2.7 (0.6, 7.8)
6.0 (0.7, 21.6)
1/249.2
0/136.2
1/113.2
2/33.8
0.4 (0.0, 2.2)
0.0 (NA, 2.7)
0.9 (0.0, 4.9)
5.9 (0.7, 21.4)
0/249.3
0/136.2
0/113.3
1/33.9
0.0 (NA, 1.5)
0.0 (NA, 2.7)
0.0 (NA, 3.3)
3.0 (0.1, 16.4)
Phase 3_Pooled
GMB
< 42
42 to < 50
50 to < 60
60 to ≤ 65
742
322
300
71
5/273.7
2/122.5
7/110.8
2/26.0
1.8 (0.6, 4.3)
1.6 (0.2, 5.9)
6.3 (2.5, 13.0)
7.7 (0.9, 27.8)
1/274.0
1/122.8
2/112.3
0/26.6
0.4 (0.0, 2.0)
0.8 (0.0, 4.5)
1.8 (0.2, 6.4)
0.0 (NA, 13.9)
0/274.1
1/123.0
1/112.4
0/26.6
0.0 (NA, 1.4)
0.8 (0.0, 4.5)
0.9 (0.0, 5.0)
0.0 (NA, 13.9)
All GMB exposure
All GMB Exposure< 42
42 to < 50
50 to < 60
60 to ≤ 65
1295
599
538
154
13/713.6
7/360.1
14/311.7
5/89.5
1.8 (1.0, 3.1)
1.9 (0.8, 4.0)
4.5 (2.5, 7.5)
5.6 (1.8, 13.0)
2/717.6
1/362.1
3/314.8
0/91.4
0.3 (0.0, 1.0)
0.3 (0.0, 1.5)
1.0 (0.2, 2.8)
0.0 (NA, 4.0)
0/718.4
1/361.6
2/314.8
0/91.4
0.0 (NA, 0.5)
0.3 (0.0, 1.5)
0.6 (0.1, 2.3)
0.0 (NA, 4.0)
  1. Abbreviations: All GMB Exposure Patients treated with any GMB dose in any duration, CI Confidence interval, EAIR Exposure-adjusted incidence rate, GMB Galcanezumab, NA Not applicable, Phase 3_Pooled all patients from the 3 placebo-controlled phase 3 trials, SMQ Standardized Medical Dictionary for Regulatory Activities query, TEAE Treatment-emergent adverse event, TPY Total patient years at risk
  2. aSMQ search included only narrow terms
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