Skip to main content

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)

From: Patient-reported outcomes to assess the efficacy of extended-release guaifenesin for the treatment of acute respiratory tract infection symptoms

  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
  1. AE: adverse event. Note: The total number of AEs includes all treatment-emergent AEs for patients. Patients may have more than one treatment-emergent AE per system organ class and preferred term. At each level of patient summarization, a patient was counted once for the most related AE.