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Table 5 Treatment-emergent adverse event (TEAEs) emerged among the 183 subjects enrolled (safety population

From: GIANT: a prospective, multicenter, real-world study on the effectiveness, safety, and tolerability of atogepant in migraine patients with multiple therapeutic failures

 

N (%)

Gradea

(according to Hartwig SC, et al [17])

  

Patients with TEAEs

10/183 (5.5)

I

II

III

• Constipation

• Nausea

• Constipation and nausea

• Hypertension

5 (2.7)

2 (1.1)

2 (1.1)

1 (0.5)

2

1

3

1

1

2

Discontinuations due to TEAEs

3 (1.6)b

 
  1. aGrade I: the adverse event occurs without requiring any adjustment to the current pharmacological therapy; Grade II: the adverse event necessitates discontinuation of the drug or adjustment of its dosage. No supplementary treatment or antidote is required; Grade III: the adverse event necessitates discontinuation of the suspected drug, whether by interruption, suspension, or modification of the therapeutic regimen, and may warrant the administration of a specific antidote
  2. bTwo subjects discontinued the treatment due to severe nausea and constipation, which were considered treatment-related. One patient discontinued due to hypertension, which was considered unrelated to the treatment