Table 5.
Adverse eventsa | Round 1 | Round 2 | Round 3 | Round 4 | Total | |||||
---|---|---|---|---|---|---|---|---|---|---|
n/N | % | (n = 206) | (n = 202) | (n = 212) | (n = 831) | |||||
Diarrhea | 15/211 | 7.1 | 14/206 | 6.8 | 19/202 | 9.4 | 17/212 | 8.0 | 65/831 | 7.8 |
Vomiting | 15/211 | 7.1 | 5/206 | 2.4 | 11/202 | 5.4 | 10/212 | 4.7 | 41/831 | 4.9 |
Fatigue/weakness | 2/211 | 0.9 | 2/206 | 1.0 | 6/202 | 3.0 | 3/212 | 1.4 | 13/831 | 1.6 |
Abdominal pain | 1/211 | 0.5 | 2/206 | 1.0 | 1/202 | 0.5 | 1/212 | 0.5 | 5/831 | 0.6 |
Itching | 1/211 | 0.5 | 5/206 | 2.4 | 6/202 | 3.0 | 2/212 | 0.9 | 14/831 | 1.7 |
Jaundice | 1/211 | 0.5 | 2/206 | 1.0 | 4/202 | 2.0 | 0/212 | 0.0 | 7/831 | 0.8 |
Headaches | 0/211 | 0.0 | 0/206 | 0.0 | 0/202 | 0.0 | 1/212 | 0.5 | 1/831 | 0.1 |
Urine discoloration | 0/211 | 0.0 | 1/206 | 0.5 | 0/202 | 0.0 | 0/212 | 0.0 | 1/831 | 0.1 |
aA child can have more than one adverse event