Table 2.
Incidence of Adverse Event and Respiratory Symptoms
| Group* | Events | Weeks† | Rate‡ | IRR (95%CI)‡ | HR (95%CI)‡ | |
|---|---|---|---|---|---|---|
| Adverse events | ||||||
| Any | Control | 24 | 144 | 1.67 | Ref | Ref |
| E-cigarette | 31 | 193 | 1.61 | 0.96 (0.57–1.66) | 0.69 (0.40–1.20) | |
| Sleep disturbance | Control | 21 | 163 | 1.29 | Ref | Ref |
| E-cigarette | 20 | 283 | 0.71 | 0.55 (0.30–1.02) | 0.64 (0.34–1.20) | |
| Nausea | Control | 14 | 209 | 0.67 | Ref | Ref |
| E-cigarette | 18 | 261 | 0.69 | 1.03 (0.51–2.11) | 0.84 (0.41–1.72) | |
| Throat/mouth irritation | Control | 7 | 244 | 0.29 | Ref | Ref |
| E-cigarette | 18 | 310 | 0.58 | 2.02 (0.88–5.21) | 1.11 (0.45–2.74) | |
| Respiratory symptoms | ||||||
| Any | Control | 19 | 164 | 1.16 | Ref | Ref |
| E-cigarette | 25 | 258 | 0.97 | 0.84 (0.46–1.54) | 1.05 (0.57–1.92) | |
| Phlegm | Control | 13 | 210 | 0.62 | Ref | Ref |
| E-cigarette | 20 | 293 | 0.68 | 1.10 (0.55–2.27) | 0.75 (0.37–1.53) | |
| Cough | Control | 14 | 200 | 0.70 | Ref | Ref |
| E-cigarette | 17 | 301 | 0.56 | 0.81 (0.40–1.66) | 1.49 (0.72–3.08) | |
| Shortness of breath | Control | 8 | 225 | 0.36 | Ref | Ref |
| E-cigarette | 12 | 332 | 0.36 | 1.02 (0.42–2.59) | 1.22 (0.48–3.10) | |
| Wheezing | Control | 6 | 249 | 0.24 | Ref | Ref |
| E-cigarette | 7 | 381 | 0.18 | 0.76 (0.25–2.37) | 0.85 (0.26–2.82) | |
There were 44 participants in the varenicline-only (control) group and 48 in the e-cigarette varenicline (e-cigarette) group.
Total person-weeks at risk of first event. For each person, this is the number of weeks from the quit date until they either experienced the event/symptom, were lost to follow-up, or completed the study (12 weeks post quit).
Incidence rate calculated per 10 person-weeks. Incidence rate ratios (IRR) and corresponding 95% confidence intervals (95%CI) estimated using log-linear rate models. Hazards ratios (HR) and corresponding 95% CIs estimated using Cox proportional-hazards models. Schoenfeld tests found some evidence for nonproportional hazards for throat/mouth irritation (p = .046) and cough (p = .032), but all other outcomes were compatible with proportionality (p > .31).