Table 3.
Relateda Adverse Events (AEs) Across Visits by Very Low Nicotine Content (VLNC) vs. Normal Nicotine Content (NNC) Condition and by Study Product Within Each Condition.
| Visits | All Relateda Adverse Events |
Related to Study Cigarettesb |
Related to ANDSb |
|||||
|---|---|---|---|---|---|---|---|---|
| VLNC |
NNC |
VLNC |
NNC |
VLNC |
NNC |
|||
| Nc | n (%)d | Nc | n (%)d | n (%)d | n (%)d | n (%)d | n (%)d | |
| Phase 2 (Week −1) | 220 | 5 (2.3%) | 218 | 5 (2.3%) | 0 (0.0%) | 0 (0.0%) | 4 (1.8%) | 4 (1.8%) |
| Phase 2 (Week 0) | 220 | 4 (1.8%) | 218 | 6 (2.8%) | 0 (0.0%) | 0 (0.0%) | 4 (1.8%) | 5 (2.3%) |
| Week 1e | 215 | 51 (23.7%) | 212 | 10 (4.7%) | 46 (21.4%) | 10 (4.7%) | 4 (1.9%) | 1 (0.5%) |
| Week 2 | 202 | 14 (6.9%) | 208 | 4 (1.9%) | 8 (4.0%) | 2 (1.0%) | 6 (3.0%) | 2 (1.0%) |
| Weeks 3–4f | 189 | 16 (8.5%) | 200 | 16 (8.0%) | 12 (6.3%) | 12 (6.0%) | 7 (3.7%) | 4 (2.0%) |
| Weeks 6 | 179 | 11 (6.1%) | 188 | 3 (1.6%) | 5 (2.8%) | 1 (0.5%) | 4 (2.2%) | 1 (0.5%) |
| Weeks 8 | 173 | 4 (2.3%) | 182 | 4 (2.2%) | 2 (1.2%) | 2 (1.1%) | 2 (1.2%) | 2 (1.1%) |
| Weeks 10 | 168 | 4 (2.4%) | 175 | 9 (5.1%) | 3 (1.8%) | 4 (2.3%) | 2 (1.2%) | 4 (2.3%) |
| Weeks 12 | 166 | 1 (0.6%) | 173 | 2 (1.2%) | 0 (0.0%) | 0 (0.0%) | 1 (0.6%) | 1 (0.6%) |
| Follow-up Week 16 | 163 | 1 (0.6%) | 173 | 1 (0.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.6%) |
Acronyms: ANDS, Alternative Nicotine Delivery Systems.
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.
Some AEs were deemed related to both study cigarettes and ANDS if products were used concurrently (during Phase 3). ANDS included e-cigarettes/vaping devices, nicotine replacement therapies (gum, lozenge, or patches), moist snuff, snus, or nicotine pouches.
Number of participants active on protocol at the clinic visit. If an active participant missed a visit, adverse events would have been attributed to the visit window closest to the start of the adverse event.
n = Number of participants with adverse event(s) reported since the previous visit; % = (n/N) × 100%.
Participants assigned to the VLNC cigarettes had an excess of AEs attributed to study cigarettes consistent with withdrawal symptoms. The eight most common AEs related to study cigarettes were (VLNC/NNC): Irritability (frustration) (13/2), Headache (incl. migraine) (8/3), Anxious (nervous) mood (8/0), Sore/itchy/irritated throat (3/4), Cough (5/1), Depressed (sad) mood (4/1), Insomnia (4/0) and Shortness of breath (3/1).
AEs reported at either Week 3 and/or Week 4 were combined as Week 3 was discontinued after COVID pause to reduce participant contact.