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pt#	dosed by	super vised	day withdrawn	reason	AE (Day = grade)	imputability	measure taken	Age (Years)	Weight (Kg)	Actual	Target	Actual	Target	Δ %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%

D0 = pre-treatment