| Any serious treatment-emergent adverse event |
2/35 (5.71) |
4/36 (11.11) |
| Any nonserious treatment-emergent adverse event |
35/35 (100.00) |
33/36 (91.67) |
| Death |
0 |
0 |
| Discontinuation of treatment because of a treatment-emergent adverse event |
0 |
0 |
| Serious treatment-emergent adverse events |
Treated |
Placebo |
| Total participants affected by serious adverse events |
2/35 (5.71) |
4/36 (11.11) |
| Surgical and medical procedures |
|
|
| Hysterectomy |
1/35 (2.86) |
0/36 (0) |
| Thyroidectomy |
0/35 (0) |
1/36 (2.78) |
| Nervous system disorders |
|
|
| Multiple sclerosis relapse with hospital admission |
0/35 (0) |
1/36 (2.78) |
| Brain hypoxia due to cardiac arrest |
0/35 (0) |
1/36 (2.78) |
| Pregnancy |
0/35 (0) |
1/36 (2.78) |
| Skin disorders |
|
|
| Allergy to synthetic fabric |
0/35 (0) |
1/36 (2.78) |
| Back pain |
0/35 (0) |
2/36 (5.56) |
| Diabetes |
1/35 (2.86) |
0/36 (0) |
| Common treatment-emergent nonserious adverse events affecting ≥5% of patients |
|
|
| Gastrointestinal tract disorders |
|
|
| Diarrhea |
9/35 (25.71) |
9/36 (25.00) |
| Abdominal discomfort |
8/35 (22.86) |
6/36 (16.67) |
| Gastroenteritis |
4/35 (11.43) |
5/36 (13.89) |
| Constipation |
1/35 (2.86) |
3/36 (8.33) |
| Nausea |
3/35 (8.57) |
0/36 (0.00) |
| Urinary tract infection |
7/35 (20.00) |
6/36 (16.67) |
| Respiratory |
|
|
| Upper tract infections |
16/35 (45.71) |
18/36 (50.00) |
| Nasopharyngitis |
3/35 (8.57) |
2/36 (5.56) |
| Lower tract infections |
3/35 (8.57) |
3/36 (8.33) |
| Cough |
2/35 (5.71) |
2/36 (5.56) |
| Chest pain |
2/35 (5.71) |
0/36 (0.00) |
| Nervous system |
|
|
| Headache |
1/35 (2.86) |
6/36 (16.67) |
| Dizziness |
0/35 (0) |
2/36 (5.56) |
| Depression |
2/35 (5.71) |
1/36 (2.78) |
| Skin |
|
|
| Reaction at plaster site |
29/35 (82.86) |
10/36 (27.78) |
| Rash |
3/35 (8.57) |
3/36 (8.33) |
| Pain of skin |
1/35 (2.86) |
2/36 (5.56) |
| Musculoskeletal |
|
|
| Pain in extremity |
2/35 (5.71) |
7/36 (19.44) |
| Back pain |
3/35 (8.57) |
2/36 (5.56) |
| Other |
|
|
| Ear infection |
0/35 (0) |
3/36 (8.33) |
| Tooth abscess |
3/35 (8.57) |
3/36 (8.33) |
| Hay fever |
1/35 (2.86) |
3/36 (8.33) |
