Table 5.
Total number of women experiencing adverse events (n), number of AEs (#), and number of AEs per 100 person weeks, by regimen
| Continuous regimen (n = 80)* |
Precoital regimen (n = 83)* |
Observation (n = 20)* |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | # | #/100 woman weeks | p1 | N | # | #/100 woman weeks | p2 | n | # | #/100 woman weeks | |
| Total | 28 | 38 | 23.8 | 0.60 | 32 | 39 | 23.5 | 1.00 | 11 | 13 | 16.3 |
| Reproductive tract (RT) or urinary tract (UT) related | 12 | 15 | 9.4 | 0.42 | 8 | 10 | 6.0 | 1.00 | 4 | 4 | 5.0 |
| Severity | |||||||||||
| Mild | 20 | 23 | 14.4 | 0.86 | 22 | 27 | 16.3 | 0.62 | 10 | 11 | 13.8 |
| RT/UT related | 5 | 6 | 3.8 | 0.75 | 7 | 8 | 4.8 | 1.00 | 3 | 3 | 3.8 |
| Moderate | 11 | 15 | 9.4 | 1.00 | 10 | 12 | 7.2 | 0.23 | 2 | 2 | 2.5 |
| RT/UT related | 7 | 9 | 5.6 | 0.07 | 1 | 2 | 1.2 | 1.00 | 1 | 1 | 1.3 |
| Severe | 0 | 0 | - | - | 0 | 0 | - | - | 0 | 0 | - |
| RT/UT related | 0 | 0 | - | - | 0 | 0 | - | - | 0 | 0 | - |
| Relatedness to study products | |||||||||||
| Definitely | 0 | 0 | - | - | 0 | 0 | - | - | - | 0 | - |
| Probably | 4 | 4 | 2.5 | 0.73 | 6 | 6 | 3.6 | - | - | 0 | - |
| Possibly | 6 | 9 | 5.6 | 0.75 | 4 | 4 | 2.4 | - | - | 0 | - |
| Probably not | 4 | 4 | 2.5 | 1.00 | 4 | 4 | 2.4 | - | - | 0 | - |
| Not related | 14 | 21 | 13.1 | 0.21 | 21 | 25 | 15.1 | - | - | 13 | - |
* Duet use participants were followed for up to 14 days per regimen. Observation group participants were followed for up to 28 days.
1 P value for the comparison of the proportion of intervention group women reporting an event during the continuous vs. precoital regimen periods (McNemar's test)
2 P value for the comparison of the proportion of women reporting an event between those in an intervention group vs. observational controls (Fisher's exact test)