Table 2– Treatment-related adverse events: overview and numbers of subjects reporting (by preferred term)
Nicotine mouth sprayPlacebo
Subjects n318161
Subjects with at least one adverse event#278 (87.4)115 (71.4)
Subjects discontinued because of an adverse event25 (7.9)11 (6.8)
Adverse events (preferred term) reported by ≥10% of subjects in either treatment group
 Hiccups182 (57.2)12 (7.5)
 Throat irritation126 (39.6)45 (28.0)
 Headache103 (32.4)58 (36.0)
 Nausea101 (31.8)39 (24.2)
 Dyspepsia93 (29.2)24 (14.9)
 Stomatitis75 (23.6)27 (16.8)
 Salivary hypersecretion68 (21.4)19 (11.8)
 Dizziness61 (19.2)39 (24.2)
 Constipation60 (18.9)28 (17.4)
 Dry mouth44 (13.8)24 (14.9)
 Dysgeusia38 (11.9)20 (12.4)
 Burning sensation in mouth38 (11.9)13 (8.1)
  • Data are presented as n (%), unless otherwise stated. #: adverse events reported by number of subjects in either treatment group who reported a treatment-related adverse event at least once. “Treatment related” was captured in the case report forms as the answer “Yes/Unknown” to the question “Is there a reasonable possibility the adverse event is related to study treatment?” All the preferred terms in the table above were included as a "health problem" prompt in the eDiary. The “health problem” prompt consisted of a checklist of 14 predefined adverse events (the 12 listed above, plus common cold and vomiting) and an “Other” option. The preferred terms dyspepsia, stomatitis, salivary hypersecretion, dysgeusia, and burning sensation in the mouth were elicited using the following adverse event prompts in the eDiary: heartburn, mouth irritation, excessive salivation, altered taste, and burning lips, respectively.