Table 4. Spontaneously reported1 adverse events: comparison by group for the total ring use period and per 100 used rings.
| Adverse events2 | Total ring use period | Rate per 100 rings3 | ||||
|---|---|---|---|---|---|---|
| Number of women (%) reporting AEs | Intermittent(N = 60) | Continuous(N = 60) | P4 | Intermittent | Continuous | P8 |
| At least one AE | 23 (38.3) | 32 (53.3) | 0.142 | 12.8 | 13.3 | 0.876 |
| One AE | 12 (20.0) | 11 (18.3) | 1.000 | 6.7 | 4.6 | 0.369 |
| Two AEs | 8 (13.3) | 10 (16.7) | 0.799 | 4.4 | 4.2 | 0.892 |
| Three AEs | 2 (3.3) | 9 (15.0) | 0.053 | 1.1 | 3.8 | 0.120 |
| Four AEs | 1 (1.7) | 1 (1.7) | 1.000 | 0.6 | 0.4 | 0.839 |
| Five AEs | 0 (0.0) | 1 (1.7) | 1.000 | 0.0 | 0.4 | NA |
| Number of AEs (%) judged | (N = 38) | (N = 67) | P5 | |||
| Mild | 13 (34.2) | 23 (34.3) | 1.000 | |||
| Moderate | 25 (65.8) | 44 (65.7) | ||||
| Not related | 3 (7.9) | 7 (10.5) | 0.308 | |||
| Unlikely related | 16 (42.1) | 19 (28.4) | ||||
| Possibly related | 18 (47.4) | 38 (56.7) | ||||
| Probably related6 | 1 (2.6) | 3 (4.5) | ||||
| Definitely related | 0 (0.0) | 0 (0.0) | ||||
| Number of women (%) reporting AEs that were reported twice or more often7 | (N = 60) | (N = 60) | P4 | Intermittent | Continuous | P8 |
| Respiratory tract infection | 7 (11.7) | 4 (6.7) | 0.529 | 3.9 | 1.7 | 0.176 |
| Headache | 6 (10.0) | 11 (18.3) | 0.295 | 3.3 | 4.6 | 0.530 |
| Back pain | 3 (5.0) | 8 (13.3) | 0.204 | 1.7 | 3.3 | 0.306 |
| Menorrhagia | 2 (3.3) | 9 (15.0) | 0.053 | 1.1 | 3.8 | 0.120 |
| Diarrhoea | 1 (1.7) | 6 (10.0) | 0.114 | 0.6 | 2.5 | 0.164 |
| Malaria | 2 (3.3) | 4 (6.7) | 0.679 | 1.1 | 1.7 | 0.640 |
| Vaginal haemorrhage | 3 (5.0) | 1 (1.7) | 0.619 | 1.7 | 0.4 | 0.230 |
| Nausea | 0 (0.0) | 4 (6.7) | 0.119 | 0.0 | 1.7 | NA |
| Vertigo | 2 (3.3) | 5 (8.3) | 0.439 | 1.1 | 2.1 | 0.452 |
| Abdominal pain | 1 (1.7) | 3 (5.0) | 0.619 | 0.6 | 1.3 | 0.483 |
| Asthma | 1 (1.7) | 1 (1.7) | 1.000 | 0.6 | 0.4 | 0.839 |
| Wound | 1 (1.7) | 1 (1.7) | 1.000 | 0.6 | 0.4 | 0.839 |
| Pustule | 1 (1.7) | 1 (1.7) | 1.000 | 0.6 | 0.4 | 0.839 |
AE = adverse event. The combination of prolonged painful menses and lower abdominal pain is coded as menorrhagia. Painful menses, prolonged menses, and heavy menstrual flow are coded as menorrhagia. Lower abdominal pain is coded as abdominal pain. Vaginal bleeding and spotting are coded as vaginal haemorrhage. Amoebiasis and intestinal parasitosis are coded as diarrhoea. Cough, flu and tonsillitis are coded as respiratory tract infection. Dizziness is coded as vertigo. The combination of nausea and vomiting is coded as nausea.
1. AEs that are not captured under the structurally collected urogenital symptoms and signs, or laboratory confirmed reproductive tract infections, which were presented in Tables 2 and 3.
2. Number of women who reported the AE (%), unless indicated otherwise.
3. Numerator: number of women reporting AEs; denominator: number of women multiplied with three (180) for intermittent users and number of women multiplied with four (240) for continuous users.
4. Fisher’s exact test comparing the proportion of women in the intermittent versus continuous use group.
5. Fisher’s exact test comparing the proportions of total AEs that were mild versus moderate, or not related/unlikely related versus possibly/probably related between study groups.
6. Intermittent users: prolonged menses; Continuous users: back pain x2 and vertigo.
7. Single presence AEs in intermittent users: loss of appetite, fever, urine tract infection, and abscess leg; in continuous users: acne, breast pain, allergic rhinitis, muscle cramp and itching of the vulva.
8. Poisson regression comparing AE rates in each study group.