Table 3.
Summary of all adverse events reported by treatment (safety population)
| Treatment | Adverse event | Duration (d) | Intensity1 | Serious | Outcome | Relation |
| Placebo | Flu/fever | 12 | 1 | No | Resolved | Not related |
| Placebo | Severe headache | 3 | 2 | No | Resolved | Not related |
| Placebo | Headache | 14 | 2 | No | Resolved | Probably related2 |
| 20 mg | Headache | 5 | 1 | No | Resolved | Possible related2 |
| 20 mg | Xerostomia | 6 | 2 | No | Resolved | Unlikely related2 |
| 20 mg | High fever | 1 | 1 | No | Resolved | Not related |
| 20 mg | Pharyngitis | 7 | 2 | No | Resolved | Not related |
| 20 mg | Pneumonia | 17 | 2 | No | Resolved | Not related |
| 40 mg | Flu/fever | 4 | 1 | No | Resolved | Not related |
| 40 mg | Asthma exacerbation | 1 | 1 | No | Resolved | Not related |
| 40 mg | GI infection | 6 | 2 | No | Resolved | Not related |
| 80 mg | Cystitis | 19 | 1 | No | Resolved | Not related |
| 80 mg | Migraine attack1 nausea | 1 | 1 | No | Resolved | Not related |
| 80 mg | Nausea | 4 | 1 | No | Resolved | Possible related2 |
1
Intensity was rated on a scale of 1-3 (1 = mild, 2 = moderate and 3 = severe);
2
Adverse events subsequently confirmed as being related to treatment. OB: Otilonium bromide; GI: Gastrointestinal.