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Table 4 Incidence rates for TEAEs, SAEs, and DCAEs

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

 Patients with One or More TEAEPatients with One or More SAEPatients with DCAE
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
397/134.7
197/78.1
177/64.3
56/18.1
294.8 (266.5, 325.2)
252.3 (218.3, 290.0)
275.2 (236.1, 318.8)
308.7 (233.2, 400.9)
8/248.1
0/136.2
2/112.8
4/33.3
3.2 (1.4, 6.4)
0.0 (NA, 2.7)
1.8 (0.2, 6.4)
12.0 (3.3, 30.7)
11/248.2
1/136.1
6/112.5
6/33.2
4.4 (2.2, 7.9)
0.7 (0.0, 4.1)
5.3 (2.0, 11.6)
18.1 (6.6, 39.3)
Phase 3_Pooled
GMB
< 42
42 to < 50
50 to < 60
60 to ≤ 65
742
322
300
71
472/143.2
202/64.9
198/54.9
41/15.8
329.6 (300.5, 360.7)
311.4 (269.9, 357.4)1
360.5 (312.0, 414.3)1
259.9 (186.5, 352.5)
10/272.1
2/122.7
9/110.8
2/25.9
3.7 (1.8, 6.8)
1.6 (0.2, 5.9)
8.1 (3.7, 15.4)
7.7 (0.9, 27.9)
22/272.3
7/122.2
5/112.2
1/26.4
8.1 (5.1, 12.2)
5.7 (2.3, 11.8)
4.5 (1.5, 10.4)
3.8 (0.1, 21.1)
Treatment-by-age group interactionp-value 0.097 0.107 0.022
All GMB exposure
All GMB Exposure< 42
42 to < 50
50 to < 60
60 to ≤ 65
1295
599
538
154
913/308.3
409/165.2
381/130.3
110/42.7
296.2 (277.3, 316.0)
247.5 (224.1, 272.7)
292.5 (263.8, 323.4)
257.7 (211.8, 310.6)
31/709.4
12/358.1
18/311.4
5/89.0
4.4 (3.0, 6.2)
3.4 (1.7, 5.9)
5.8 (3.4, 9.1)
5.6 (1.8, 13.1)
51/714.3
18/359.9
18/313.8
4/91.0
7.1 (5.3, 9.4)
5.0 (3.0, 7.9)
5.7 (3.4, 9.1)
4.4 (1.2, 11.3)
  1. Abbreviations: All GMB Exposure, patients treated with any GMB dose in any duration, CI Confidence interval, DCAE Discontinuation due to adverse event, EAIR Exposure-adjusted incidence rate, GMB Galcanezumab, Phase 3_Pooled all patients from the 3 placebo-controlled phase 3 trials, SAE Serious adverse event, TEAE Treatment-emergent adverse event, TPY Total patient years at risk
  2. 1p ≤ 0.05 compared with placebo
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