Table 2.
Treatment-emergent adverse events, overall and by any comorbidity subgroup
| Placebo | Duloxetine 60 mg QD | ||||||
|---|---|---|---|---|---|---|---|
| Event (≥ 5% and twice rate of placebo overall) | Comorbidity stratum | N | n (%) | N | n (%) | Treatment p-value* | Treatment-by-subgroup p-value† |
| Patients with ≥ 1 TEAEs | Overall | 104 | 67 (64.4) | 207 | 145 (70.0) | 0.367 | – |
| Yes | 78 | 54 (69.2) | 155 | 105 (67.7) | 0.882 | 0.030 | |
| No | 26 | 13 (50.0) | 52 | 40 (76.9) | 0.022 | ||
| Dry mouth | Overall | 104 | 2 (1.9) | 207 | 30 (14.5) | < 0.001 | – |
| Yes | 78 | 2 (2.6) | 155 | 23 (14.8) | 0.003 | 0.440 | |
| No | 26 | 0 (0.0) | 52 | 7 (13.5) | 0.088 | ||
| Nausea | Overall | 104 | 4 (3.8) | 207 | 26 (12.6) | 0.014 | – |
| Yes | 78 | 3 (3.8) | 155 | 19 (12.3) | 0.055 | 0.933 | |
| No | 26 | 1 (3.8) | 52 | 7 (13.5) | 0.257 | ||
| Constipation | Overall | 104 | 5 (4.8) | 207 | 21 (10.1) | 0.131 | – |
| Yes | 78 | 4 (5.1) | 155 | 12 (7.7) | 0.588 | 0.311 | |
| No | 26 | 1 (3.8) | 52 | 9 (17.3) | 0.151 | ||
| Dizziness | Overall | 104 | 3 (2.9) | 207 | 17 (8.2) | 0.087 | – |
| Yes | 78 | 3 (3.8) | 155 | 13 (8.4) | 0.275 | 0.345 | |
| No | 26 | 0 (0.0) | 52 | 4 (7.7) | 0.295 | ||
| Diarrhoea | Overall | 104 | 2 (1.9) | 207 | 17 (8.2) | 0.042 | – |
| Yes | 78 | 2 (2.6) | 155 | 12 (7.7) | 0.150 | 0.366 | |
| No | 26 | 0 (0.0) | 52 | 5 (9.6) | 0.163 | ||
| Fatigue | Overall | 104 | 3 (2.9) | 207 | 13 (6.3) | 0.279 | – |
| Yes | 78 | 1 (1.3) | 155 | 10 (6.5) | 0.105 | 0.135 | |
| No | 26 | 2 (7.7) | 52 | 3 (5.8) | 1.000 | ||
| Somnolence | Overall | 104 | 1 (1.0) | 207 | 11 (5.3) | 0.067 | – |
| Yes | 78 | 1 (1.3) | 155 | 7 (4.5) | 0.274 | 0.455 | |
| No | 26 | 0 (0.0) | 52 | 4 (7.7) | 0.295 | ||
*
Significant (p ≤ 0.05) within-stratum treatment comparison p-values are bolded if the treatment-by-subgroup p-value is statistically significant (p ≤ 0.10).
†
Significant (p ≤ 0.10) treatment-by-subgroup p-values are bolded.