Table 5. Subject disposition summary.
| Smokers |
Never smokers | Total | ||||
|---|---|---|---|---|---|---|
| TH | S | TB | Overall | |||
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| Intent-to-treat | ||||||
| Overall | 44 (27) | 43 (26) | 44 (27) | 131 (80) | 32 (20) | 163 (100) |
| Randomized | 44 (100) | 43 (100) | 44 (100) | 131 (100) | NA d | 131 (100) |
| Completed | 34 (77) | 29 (67) | 35 (80) | 98 (75) | 32 (100) | 130 (80) |
| Withdrawal | 10 (23) | 14 (33) | 9 (21) | 33 (25) | 0 | 33 (20) |
| Adverse events a | 0 | 0 | 1 (2) | 1 (1) | 0 | 1 (1) |
| Sponsor discontinued b | 1 (2) | 0 | 0 | 1 (1) | 0 | 1 (1) |
| Consent withdrawn | 6 (14) | 11 (26) | 5 (11) | 22 (17) | 0 | 22 (14) |
| Product related | 3 | 7 | 0 | 10 | 0 | 10 |
| Not product related | 3 | 4 | 5 | 12 | 0 | 12 |
| Lost to follow-up | 0 | 1 (2) | 2 (5) | 3 (2) | 0 | 3 (2) |
| Other c | 3 (7) | 2 (5) | 1 (2) | 6 (5) | 0 | 6 (4) |
| Per-protocol | ||||||
| Overall | 33 (28) | 20 (17) | 35 (29) | 88 (73) | 32 (27) | 120 (100) |
| Randomized | 33 (100) | 20 (100) | 35 (100) | 88 (100) | NA d | 88 (73) |
| Completed | 33 (100) | 20 (100) | 35 (100) | 88 (100) | 32 (100) | 120 (100) |
TH, switched to tobacco-heating cigarette; S, switched to snus; TB, switched to ultra-low machine yield tobacco-burning cigarette. Percent values have been rounded.
aSepsis; a serious AE, not study product nor procedure related; subject required hospitalization and was discontinued by the Principal Investigator.
bSubject developed benign mouth sores; off study product long enough that subject was discontinued from study.
cNon-compliance, family emergency.
dNot applicable. Never smokers were not randomized.