Table 4.
Relateda Adverse Events (AEs) Reported at ≥2%; AEs by Very Low Nicotine Content (VLNC) vs. Normal Nicotine Content (NNC) Condition and by Study Product Within Each Condition During Phase 3.
| All Related AEsa |
Related: Study Cigarettesb |
Related: ANDSb |
|||||
|---|---|---|---|---|---|---|---|
| VLNC (N = 220) |
NNC (N = 218) |
% Differenced (95% CI) |
VLNC |
NNC |
VLNC |
NNC |
|
| n (%)c | n (%)c | n (%)c | n (%)c | n (%)c | n (%)c | ||
| Gastrointestinal disorders | |||||||
| Vomiting | 5 (2.27%) | 2 (0.92%) | 1.35 (−1.00, 3.70) | 1 (0.45%) | 2 (0.92%) | 3 (1.36%) | 1 (0.46%) |
| Stomach upset/pain | 9 (4.09%) | 5 (2.29%) | 1.80 (−1.49, 5.09) | 5 (2.27%) | 2 (0.92%) | 5 (2.27%) | 2 (0.92%) |
| Nervous system disorders | |||||||
| Headache (incl. migraine) | 15 (6.82%) | 3 (1.38%) | 5.44 (1.75, 9.13) | 10 (4.55%) | 2 (0.92%) | 4 (1.82%) | 1 (0.46%) |
| Psychiatric disorders | |||||||
| Anger | 7 (3.18%) | 0 (0%) | 3.18 (0.84, 5.52) | 7 (3.18%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Anxious (nervous) mood | 10 (4.55%) | 5 (2.29%) | 2.26 (−1.14, 5.66) | 10 (4.55%) | 3 (1.38%) | 0 (0%) | 1 (0.46%) |
| Insomnia (change/disturbance in sleep) | 6 (2.73%) | 1 (0.46%) | 2.27 (−0.08, 4.62) | 5 (2.27%) | 0 (0%) | 1 (0.45%) | 0 (0%) |
| Irritability (frustration) | 16 (7.27%) | 8 (3.67%) | 3.60 (−0.65, 7.85) | 16 (7.27%) | 6 (2.75%) | 0 (0%) | 1 (0.46%) |
| Respiratory, Thoracic, Mediastinal disorders | |||||||
| Cough | 9 (4.09%) | 2 (0.92%) | 3.17 (0.25, 6.09) | 6 (2.73%) | 1 (0.46%) | 2 (0.91%) | 1 (0.46%) |
| Phlegm increase | 5 (2.27%) | 2 (0.92%) | 1.35 (−1.00, 3.70) | 3 (1.36%) | 2 (0.92%) | 2 (0.91%) | 0 (0%) |
| Sore throat (incl. Itchy/irritated throat) | 7 (3.18%) | 4 (1.83%) | 1.35 (−1.58, 4.28) | 5 (2.27%) | 3 (1.38%) | 2 (0.91%) | 1 (0.46%) |
Acronyms: ANDS, Alternative Nicotine Delivery Systems; CI, Confidence Interval.
AE deemed Definitely Related, Possibly Related, or Relationship Unknown to study product as assessed by the site's licensed medical professional. All related AEs also include AEs attributed to study procedures (nine participants and one participant's AE attributed to both study procedure and study cigarette).
Some AEs were deemed related to both study cigarettes and ANDS if products were used concurrently. ANDS included e-cigarettes/vaping devices, nicotine replacement therapies (gum, lozenge, or patches), moist snuff, snus, or nicotine pouches.
n = Number of participants with adverse event(s) reported; % = (n/N) × 100%.
The percent of participants reporting a specific adverse event in the VLNC condition minus that in the NNC condition. Differences are bolded if confidence interval does not include zero.