Table 2.
Adverse Event (MedDRA “preferred terms”) | DOX 200 mg | DOX 100 mg | Placebo | Total |
---|---|---|---|---|
Diarrhea | 4 (28.6%) | 6 (42.9%) | 4 (28.6%) | 14 |
Headache | 5 (38.5%) | 6 (46.2%) | 2 (15.4%) | 13 |
Pain | 3 (23.1%) | 6 (46.2%) | 4 (30.8%) | 13 |
Transaminases Increased | 3 (23.1%) | 5 (38.5%) | 5 (38.5%) | 13 |
Pain in Extremity | 4 (33.3%) | 6 (50%) | 2 (16.7%) | 12 |
Vomiting | 2 (33.3%) | 3 (50%) | 1 (16.7%) | 6 |
Abdominal Pain | 3 (75%) | 1 (25%) | 0 | 4 |
Pruritus | 2 (50%) | 1 (25%) | 1 (25%) | 4 |
Pyrexia | 2 (50%) | 1 (25%) | 1 (25%) | 4 |
Arthralgia | 0 | 2 (66.7%) | 1 (33.3%) | 3 |
Other* | 7 (41.2%) | 5 (29.4%) | 5 (29.4%) | 17 |
Total | 35 (34%) | 42 (40.8%) | 26 (25.2%) | 103 |
DOX = doxycycline.
Other: occurrence <3 (increased blood pressure, malaise, palpitations, arthropod sting, blisters, chills, cough, eye inflammation, gangrene, infection, myalgia, nail injury, peripheral swelling, rash pruritic).