Table 4 TESS requiring withdrawal from the study. All patients received the co-blistered product.
Dose (mg/d) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AS | AQ | |||||||||||||
pt# | dosed by | super vised | day withdrawn | reason | AE (Day = grade) | imputability | measure taken | Age (Years) | Weight (Kg) | Actual | Target | Actual | Target | Δ % |
108 | age | yes | 3 | vomiting | D0 = 2; D1 = 2; D2 = 1 | possible | metopimazine i.m. | 19 | 49 | 200 | 196 | 612 | 490 | 20% |
167 | age | yes | 2 | vomiting | D1 = 2 | probable | metopimazine i.m. + quinine i.m. | 18 | 47 | 200 | 188 | 612 | 470 | 23% |
186 | weight | yes | 2 | abdominal pain | D1 = 2 | probable | phloroglucinol p.o+quinine i.m. | 19 | 77 | 200 | 308 | 612 | 770 | -26% |
212 | weight | yes | 2 | abdominal pain + weakness | D1 = 2 | probable | phloroglucinol p.o+quinine i.m. | 14 | 49 | 200 | 196 | 612 | 490 | 20% |
266 | age | no | 3 | vomiting | D1 = 2 | probable | hospitalized: metopimazine i.v. + quinine i.v. | 11 | 36 | 100 | 144 | 306 | 360 | -18% |
464 | age | no | 3 | vomiting | D1 = 2 | probable | hospitalized: metopimazine i.v. + quinine i.v. | 1 1/2 | 8.8 | 50 | 35.2 | 153 | 88 | 42% |
116 | age | no | 2 | vomiting | D1 = 2 | probable | metopimazine i.m. + quinine i.m. | 18 | 47 | 200 | 188 | 612 | 470 | 23% |
8 | age | no | 3 | vertigo | D1 = 2, D2 = 2 | probable | none | 16 | 53 | 200 | 212 | 612 | 530 | 13% |
87 | age | no | 3 | pruritus | D1 = 2, D2 = 2, D3 = 2 | probable | dexchlorphe - niramine p.o. | 16 | 59 | 200 | 236 | 612 | 590 | 4% |