Table 3.
Number of participants in each treatment for whom adverse event reports were obtained and number (and percentage) of participants in each treatment reporting any adverse event and specific types of adverse events during each study period
| Adverse event/symptom | Study period | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Follow-up | |||||
| Oxytocin n = 47 |
Placebo n = 43 |
Oxytocin n = 47 |
Placebo n = 41 |
Oxytocin n = 44 |
Placebo n = 40 |
Oxytocin n = 44 |
Placebo n = 37 |
|
| Any | 31 (66.0%) | 21 (48.8%) | 27 (57.4%) | 20 (48.8%) | 24 (54.5%) | 21 (52.5%) | 23 (52.3%) | 14 (37.8%) |
| Abdominal stomach pain | 2 (4.3%) | 0 (0.0%) | 2 (4.3%) | 0 (0.0%) | 2 (4.5%) | 0 (0.0%) | 2 (4.5%) | 0 (0.0%) |
| Cough with phlegm | 7 (14.9%) | 6 (14%) | 4 (8.5%) | 5 (12.2%) | 5 (11.4%) | 5 (12.5%) | 7 (15.9%) | 4 (10.8%) |
| Drowsiness | 7 (14.9%) | 7 (16.3%) | 4 (8.5%) | 5 (12.2%) | 5 (11.4%) | 6 (15%) | 5 (11.4%) | 2 (5.4%) |
| Dry throat | 8 (17%) | 5 (11.6%) | 6 (12.8%) | 2 (4.9%) | 7 (15.9%) | 2 (5.0%) | 6 (13.6%) | 2 (5.4%) |
| Fainting | 1 (2.1%) | 1 (2.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (2.5%) | 1 (2.3%) | 0 (0.0%) |
| Fever | 1 (2.1%) | 2 (4.7%) | 0 (0.0%) | 1 (2.4%) | 0 (0.0%) | 2 (5.0%) | 0 (0.0%) | 0 (0.0%) |
| Heart rate change or palpitations | 1 (2.1%) | 2 (4.7%) | 2 (4.3%) | 2 (4.9%) | 2 (4.5%) | 2 (5.0%) | 1 (2.3%) | 0 (0.0%) |
| Hoarseness | 6 (12.8%) | 2 (4.7%) | 3 (6.4%) | 2 (4.9%) | 7 (15.9%) | 1 (2.5%) | 5 (11.4%) | 1 (2.7%) |
| Light-headedness | 4 (8.5%) | 5 (11.6%) | 3 (6.4%) | 4 (9.8%) | 3 (6.8%) | 3 (7.5%) | 3 (6.8%) | 1 (2.7%) |
| Nasal irritation | 3 (6.4%) | 2 (4.7%) | 9 (19.1%) | 2 (4.9%) | 4 (9.1%) | 3 (7.5%) | 5 (11.4%) | 0 (0.0%) |
| Nausea | 1 (2.1%) | 0 (0.0%) | 3 (6.4%) | 0 (0.0%) | 1 (2.3%) | 2 (5%) | 0 (0.0%) | 1 (2.7%) |
| Runny nose | 13 (27.7%) | 7 (16.3%) | 9 (19.1%) | 12 (29.3%) | 9 (20.5%) | 11 (27.5%) | 12 (27.3%) | 7 (18.9%) |
| shortness of breath | 2 (4.3%) | 1 (2.3%) | 3 (6.4%) | 1 (2.4%) | 1 (2.3%) | 0 (0.0%) | 6 (13.6%) | 1 (2.7%) |
| Sneezing | 10 (21.3%) | 9 (20.9%) | 10 (21.3%) | 9 (22%) | 6 (13.6%) | 7 (17.5%) | 6 (13.6%) | 5 (13.5%) |
| Sore throat | 2 (4.3%) | 2 (4.7%) | 2 (4.3%) | 3 (7.3%) | 4 (9.1%) | 3 (7.5%) | 3 (6.8%) | 2 (5.4%) |
| Stuffed-up nose | 13 (27.7%) | 5 (11.6%) | 10 (21.3%) | 8 (19.5%) | 8 (18.2%) | 11 (27.5%) | 13 (29.5%) | 6 (16.2%) |
| Tearing of the eyes | 6 (12.8%) | 0 (0.0%) | 8 (17.0%) | 6 (14.6%) | 5 (11.4%) | 4 (10.0%) | 7 (15.9%) | 1 (2.7%) |
There were no significant differences between groups in the number of any symptoms reported (top row) across study weeks; the only significant difference between groups by symptom type was in “Tearing of the eyes” during week 1. Percentages are always calculated based on the number of reports obtained in each time period, per group (i.e., not based on the total possible sample). Symptoms or the lack thereof from reports coded as “early” (n = 3) are not included in the frequencies/percentages