Table 4.
Most Frequent Adverse Events Reported in the Safety Population
| Variables | Artesunate– Amodiaquine, n = 190 (%)a | Chloroquine, n = 190 (%) |
|---|---|---|
| All AEs | ||
| Patients with at least 1 event | 79 (41.6) | 85 (44.7) |
| Cardiac disorders | 35 (18.4) | 21 (11.1) |
| Skin disorders | 14 (7.4) | 23 (12.1) |
| Infections and infestations | 16 (8.4) | 21 (11.1) |
| Gastrointestinal disorders | 16 (8.4) | 15 (7.9) |
| Psychiatric disorders/insomnia | 8 (4.2) | 12 (6.3) |
| Drug-related AEsb | ||
| Patients with at least 1 of the following: | 59 (31.1) | 47 (14.7) |
| Sinus bradycardia | 28 (14.7) | 11 (5.8) |
| Pruritus | 13 (6.8) | 19 (10.0) |
| Increased ALAT | 9 (4.7) | 8 (4.2) |
| Gastritis | 8 (4.2) | 5 (2.6) |
| Vomiting | 6 (3.2) | 5 (2.6) |
| Insomnia | 2 (1.1) | 4 (2.1) |
| Diarrhea | 2 (1.1) | 0 (0.0) |
| At least 1 event of special interest | 8 (4.2) | 9 (4.7) |
| Increased ALATc | 8 (4.2) | 8 (4.2) |
| Neutropeniad | 0 | 1 (0.5) |
| Serious AEs¶ | ||
| Patients presenting at least 1 serious AE* | 3 (1.6) | 0 |
| Vomiting | 3 | 0 |
| Severe gastritis | 1 | 0 |
| Extrapyramidal syndrome | 1 | 0 |
Only AEs that affected at least 4% in each group are listed.
Abbreviations: AE, adverse event; ALAT, alanine aminotransferase.
a The patient with mixed infection detected by polymerase chain reaction was included in the safety analyses.
b Only events that affected at least 1% of the population in each group are listed.
c ALAT >5 × upper limit of normal (ULN) value, or ALAT >3 × ULN if ALAT was >ULN on day 0, or ALAT >3 × ULN associated with total bilirubin >2×ULN.
d Neutrophil count <400/mm3 in children aged 3 months to 12 years or <750/mm3 in children aged >12 years or adults. ¶Events were classified as serious AEs based on the need for intravenous medication to alleviate the symptoms.
*There were no investigational product discontinuation or deaths in the study. Full recovery occurred for all AEs.