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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)a

Embolic and Thrombotic events (SMQ)a

Ischemic heart disease (SMQ)a

Dose Group

Age Group (years)

N

n/TPY

EAIR (95% CI)

n/TPY

EAIR (95% CI)

n/TPY

EAIR (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