Table 3. Adherence and Adverse Events in Lower (35-50 mg/kg per Day) and Higher (70-90 mg/kg per Day) Dose and Shorter (3-Day) and Longer (7-Day) Duration Groups.
| Outcome | Amoxicillin dose | Amoxicillin duration | ||||||
|---|---|---|---|---|---|---|---|---|
| 35-50 mg/kg per Day (n = 410) | 70-90 mg/kg per Day (n = 404) | Difference, % (95% CI) | P value | 3 Days (n = 413)a | 7 Days (n = 401)a | Difference, % (95% CI) | P value | |
| Adherence: complete course taken | ||||||||
| All treatmenta | 355 (87) | 366 (91) | –4 (–8 to –0) | .07 | 358 (87) | 363 (91) | –4 (–8 to 1) | .09 |
| Active treatment onlyb | 383 (93) | 384 (95) | –2 (–5 to 2) | .32 | 404 (98) | 363 (91) | 7 (4 to 10) | <.001 |
| Adherence: all doses taken and all volumes as prescribed | ||||||||
| All treatmentb | 306 (75) | 309 (76) | –2 (–8 to 4) | .54 | 300 (73) | 315 (79) | –6 (–12 to –0) | .05 |
| Active treatment onlyc | 352 (86) | 350 (87) | –1 (–6 to 4) | .75 | 387 (94) | 315 (79) | 15 (11 to 20) | <.001 |
| Clinical possibly drug-related adverse events post enrollment | ||||||||
| Diarrhea | 168 (42) | 177 (45) | –4 (–10 to 3) | .31 | 187 (46) | 158 (41) | 6 (–1 to 12) | .11 |
| Oral thrush | 27 (7) | 30 (8) | –1 (–5 to 3) | .60 | 25 (6) | 32 (8) | –2 (–6 to 2) | .26 |
| Rash | 94 (23) | 99 (25) | –2 (–8 to 4) | .52 | 87 (22) | 106 (27) | –6 (–12 to –0) | .06 |
| Serious adverse event, any d | 23 (6) | 20 (5) | 1 (–2 to 4) | .67 | 25 (6) | 18 (4) | 2 (–2 to 5) | .32 |
a
Courses were considered complete when trial drug was taken on all 7 days.
b
Including nonadherence to placebo.
c
Ignoring nonadherence to placebo.
d
No participant had more than 1 serious adverse event, all serious adverse events were hospitalizations (most for respiratory distress), no deaths. The data stratified by randomization groups can be found in eTable 10 in Supplement 2.