TABLE 1.
Incidence rates per person-year by drug arm (azithromycin, doxycycline, and placebo) for all symptoms voluntarily reported daily over the 20 weeks of the trial and significant RR comparisonsa
| Symptom | Azithromycin symptoms (rate)b | A vs P RR (95% CIc) | Placebo symptoms (rate)c | D vs P RR (95% CI) | Doxycycline symptoms (rate)b |
|---|---|---|---|---|---|
| All | 1,525 (40.22) | 416 (38.22) | 852 (39.75) | ||
| Gastrointestinal | 323 (8.51) | 104 (9.55) | 161 (7.51) | ||
| Anorexia | 104 (2.74) | 39 (3.58) | 0.56 (0.35-0.89) | 43 (2.0) | |
| Nausea | 53 (1.39) | 19 (1.74) | 35 (1.63) | ||
| Vomiting | 11 (0.29) | 6 (0.55) | 5 (0.23) | ||
| Heartburnd | 73 (1.92) | 10.48 (2.79-88.14) | 2 (0.18) | 6.35 (1.58-55.3) | 25 (1.17) |
| Mild abdominal pain | 43 (1.13) | 18 (1.65) | 25 (1.17) | ||
| Severe abdominal pain | 2 (0.05) | 0 (0) | 10.7 (1.14-∞)e | 10 (0.47)f | |
| Diarrhea | 34 (0.89) | 18 (1.65) | 18 (0.84) | ||
| Diarrhea, >5/day | 3 (0.08) | 2 (0.18) | 0 (0) | ||
| Central nervous system | 492 (12.98) | 151 (13.88) | 278 (12.97) | ||
| Mild headache | 227 (5.98) | 64 (5.88) | 119 (5.55) | ||
| Severe headache | 14 (0.37) | 8 (0.73) | 7 (0.33) | ||
| Dizzinessg | 100 (2.63) | 19 (1.75) | 2.06 (1.23-3.6) | 77 (3.59) | |
| Tinnitus | 9 (0.24) | 0.10 (0.04-0.21) | 27 (2.48) | 0.13 (0.05-0.31) | 7 (0.33) |
| Hearing loss | 9 (0.24) | 5 (0.46) | 6 (0.28) | ||
| Blurred vision | 6 (0.16) | 4 (0.37) | 7 (0.33) | ||
| Paresthesiad | 78 (2.06) | 2.04 (1.08-4.24) | 11 (1.01) | 0.23 (0.06-0.72) | 5 (0.23) |
| Difficulty sleeping | 49 (1.3) | 13 (1.2) | 1.91 (1.02-3.84) | 49 (2.29)f | |
| Hallucinations | 0 (0) | 0 (0) | 1 (0.05) | ||
| Dermatological | 160 (4.22) | 1.84 (1.20-2.92) | 25 (2.3) | 1.65 (1.04-2.69) | 81 (3.78) |
| Mild itching | 135 (3.56) | 1.55 (1.01-2.48) | 25 (2.3) | 75 (3.49) | |
| Severe itchingd | 19 (0.5) | 11.2 (1.34-∞)e | 0 (0) | 2 (0.09) | |
| Rash | 6 (0.16) | 0 (0) | 4 (0.19) | ||
| Miscellaneous | 207 (5.46) | 71 (6.52) | 144 (6.72) | ||
| Cough | 143 (3.77) | 43 (3.95) | 94 (4.39) | ||
| Fever | 11 (0.29) | 0.21 (0.09-0.49) | 15 (1.38) | 0.37 (0.15-0.87) | 11 (0.51) |
| Chills | 10 (0.26) | 2 (0.18) | 5 (0.23) | ||
| Sweats | 10 (0.26) | 4 (0.37) | 13 (0.60) | ||
| Myalgia | 33 (0.87) | 7 (0.64) | 21 (0.98) | ||
| Others | 343 (9.05) | 1.51 (1.16-2.01) | 65 (5.97) | 1.47 (1.1-1.98) | 188 (8.77) |
Person-years of follow-up were 37.91 (arm A), 10.88 (arm P), and 21.43 (arm D).
Values are total numbers of symptoms reported, with incidence rates per person-year given in parentheses.
95% CI, 95% confidence interval.
A versus D: heartburn RR = 1.6 (95% CI, 1.04-2.7), paresthesia RR = 8.8 (3.6-27.9), and itching (severe) RR = 5.3 (1.3-47.5).
A value of 0.5 was added to the numerator and denominator symptom counts to estimate the RR if the denominator count was 0; 95% confidence intervals were calculated by using the observed data (no adjustment was made to the numerator or denominator).
D versus A: abdominal pain (severe) RR = 8.85 (95% CI, 1.89-83.03), and difficulty sleeping RR = 1.77 (1.17-2.68).
Dizziness and/or muzzy head.