Table 8.
Treatment-related AEs in >2% of patients in any treatment group in studies A0661120 (India), A0661126 (Colombia/Suriname), and A0661154 (Colombia/India)
| AZCQ 2 g (n = 110)
|
AZCQ 1 g (n = 197)
|
AZCQ 500 mg (n = 81)
|
SPCQ (n = 80)
|
AP (n = 116)
|
|
|---|---|---|---|---|---|
| n (%) of patients | |||||
| Any AE | 48 (44) | 52 (26) | 8 (10) | 4 (5) | 14 (12) |
| Pruritus | 4 (4) | 30a (15) | 5 (6) | 0 | 2 (2) |
| Diarrhea | 13 (12) | 7 (4) | 0 | 0 | 4 (3) |
| Paresthesia | 0 | 6 (3) | 0 | 0 | 0 |
| Abdominal pain | 0 | 5 (3) | 0 | 0 | 4 (3) |
| Headache | 0 | 3 (2) | 0 | 0 | 1 (1) |
| Gastritis | 4 (4) | 4 (2) | 1 (1) | 0 | 0 |
| Vomitingb | 20 (18) | 7 (4) | 1 (1) | 3 (4) | 1 (1) |
| Nausea | 33 (30) | 0 | 0 | 0 | 0 |
| Dehydration | 4 (4) | 0 | 0 | 0 | 0 |
Notes:
a
28/30 patients with pruritus from Colombia/Suriname.
b
One patient on AZCQ 2 g complained of severe vomiting.
Abbreviations: AE, adverse event; AP, atovaquone–proguanil; AZCQ, azithromycin–chloroquine; SPCQ, chloroquine plus sulfadoxine–pyrimethamine.