Table 5 Summary of treatment-related (possible/probable) AEs (all causalities), by system organ class and preferred term, occurring in ≥ 0.5% of patients in either treatment group (safety population)
Placebo | ER guaifenesin | |||
|---|---|---|---|---|
System organ class | (n = 189) | (n = 188) | ||
Preferred term | Possible | Probable | Possible | Probable |
Total number of treatment-emergent AEs | 4 | 2 | 7 | 5 |
Number of unique patients with at least one AE | 2.1 | 1.1 | 3.7 | 2.7 |
Gastrointestinal disorders % | 1.6 | 0.5 | 0.5 | 1.6 |
Abdominal discomfort % | 0.5 | 0 | 0 | 0 |
Diarrhoea % | 0.5 | 0 | 0 | 0 |
Dry mouth % | 0 | 0.5 | 0 | 0 |
Nausea % | 0 | 0 | 0.5 | 1.6 |
Vomiting % | 0.5 | 0 | 0 | 0 |
Nervous system disorders % | 0 | 0.5 | 3.2 | 0.5 |
Headache % | 0 | 0.5 | 2.1 | 0.5 |
Sinus headache % | 0 | 0 | 0.5 | 0 |
Somnolence, % | 0 | 0 | 0.5 | 0 |
Psychiatric disorders % | 0 | 0 | 0 | 0.5 |
Insomnia % | 0 | 0 | 0 | 0.5 |
Skin and subcutaneous tissue disorders % | 0.5 | 0 | 0 | 0 |
Rash % | 0.5 | 0 | 0 | 0 |