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Table 2 Incidence of treatment-emergent adverse events occurring in ≥1 patient overall in each study

From: Complementary pharmacokinetic measures to further define the profile of once-daily OROS hydromorphone ER during single-dose and steady-state dosing

Adverse event, n (%)

OROS hydromorphone ER

IR hydromorphone, fasted (n = 30)

Fed (n = 29)

Fasted (n = 30)

Study A

Headache

2 (7)

3 (10)

1 (3)

Dizziness

1 (3)

1 (3)

1 (3)

Constipation

1 (3)

1 (3)

1 (3)

Abdominal pain, upper

1 (3)

1 (3)

0 (0)

Nausea

2 (7)

0 (0)

0 (0)

Vomiting

1 (3)

1 (3)

0 (0)

Hyperhidrosis

1 (3)

1 (3)

0 (0)

Study B

OROS hydromorphone ER (n = 29)

IR hydromorphone (n = 30)

Chest pain

2 (6.9)

2 (6.7)

Erythema

2 (6.9)

1 (3.3)

Pruritus

2 (6.9)

1 (3.3)

Constipation

1 (3.4)

1 (3.3)

Fatigue

1 (3.4)

1 (3.3)

Headache

1 (3.4)

1 (3.3)

Somnolence

1 (3.4)

1 (3.3)

  1. ER, extended-release; IR, immediate-release.