Table 3

Treatment-emergent adverse events (%) with significant treatment-by-tiredness subgroup interaction

P-value (treatment-by-tiredness subgroup)

Mild subgroup

Moderate subgroup

Severe subgroup

Placebo

(n = 20)

(%)

Duloxetine

(n = 29)

(%)

Placebo

(n = 83)

(%)

Duloxetine

(n = 133)

(%)

Placebo

(n = 430)

(%)

Duloxetine

(n = 634)

(%)

Patients with ≥1 TEAE

0.040

90.0

96.6

73.5

91.0

77.7

82.0

Hypoaesthesia

0.094

10.0

0.0

1.2

1.5

1.2

2.1

Arthralgia

0.008

10.0

0.0

9.6

2.3

2.8

3.8

Cough

0.034

15.0

0.0

1.2

3.0

2.6

3.2

Myalgia

0.081

10.0

3.5

0.0

3.8

1.6

3.3

Bronchitis

0.014

5.0

0.0

3.6

0.0

2.3

3.3

Influenza

0.019

0.0

3.5

6.0

0.8

1.4

2.5

Palpitations

0.085

0.0

3.5

4.8

1.5

2.5

1.2

Restless leg syndrome

0.030

5.0

0.0

0.0

3.0

1.4

0.6

Osteoarthritis

0.029

10.0

0.0

3.6

0.0

0.7

0.8

TEAE, treatment-emergent adverse event.

Bradley et al. Arthritis Research & Therapy 2010 12:R141   doi:10.1186/ar3081