Table 4.
Adverse events in individual patients with severe renal impairment at baseline
| Treatment group | Age | Sex | Event (LLT)a | Relatedb | Serious |
|---|---|---|---|---|---|
| Olodaterol 5 μg | 70 | M | None reported | – | – |
| 79 | M | Cellulitis of leg | N | N | |
| Bronchopneumonia, COPD exacerbation | N | N | |||
| Cellulitis of oral soft tissues | N | N | |||
| Chest tightness | N | N | |||
| Epigastric pain | N | N | |||
| Tiotropium 5 μg | – | – | None reported | – | – |
| Tiotropium/olodaterol 5/5 μg | 80 | M | Chest pain (at screening before randomization–no study medication received) | N | N |
| Upper respiratory tract infection | N | N | |||
| Bronchitis, COPD exacerbation | N | N | |||
| 80 | F | Urinary infection | N | N | |
| Upper respiratory tract infection | N | N | |||
| Headache | N | N | |||
| 76 | M | Dysgeusia, insomnia, sudoresis, tremor | Y | N |
Notes:
a
After start of randomized study medication.
b
Reported by the investigator with a reasonable possibility of being drug-related.
Abbreviations: F, female; LLT, Medical Dictionary for Regulatory Activities Low Level Term; M, male; N, no; Y, yes.