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. Author manuscript; available in PMC: 2015 Apr 1.
Published in final edited form as: Gastroenterology. 2013 Dec 31;146(4):914–928. doi: 10.1053/j.gastro.2013.12.032

Table 2. Presenting clinical features and outcomes in Prospective studies of DILI.

Feature DILIN US N=300
(ref 32)
Spain N=446
(ref 23)
Japan N=1676
(ref 26)
Iceland N=96
(ref 24)
France N=34
(ref 33)

Study Design Multicenter (8 sites) ‘04 to ‘08 Multicenter (32 sites) ’94-‘05 Multicenter ’97-‘06 Population based ’10-‘12 Population based ’97-‘01

Causality method Expert opinion RUCAM RUCAM RUCAM CIOMS

F/U duration (mon) 6 to 24 3 NA 3 3

Mean age (yrs) 48 53 55 55 55

% Female 60% 49% 57% 56% 65%

Race
 % Caucasian 79% 100% 0% 100% 100%
 % African Amer 11% 0%
 % Asian 4% 100%
 % Other 6% 0%

Liver injury type
 % Hepatocellular 57% 58% 59% 42% 53%
 % Mixed/Cholestatic 20%/23% 22%/20% 20%/21% 26%/32% 26%/21%

% Jaundice 69% 71% NA 27% 29%

% Liver biopsy 50% 25% NA 11% NA

% Hospitalized 60% 53% NA 23% 12%

% Died or transplanted 10% 7% 3.7% 11% 6%

% Chronic 14% 10% 8.4% 7% NA

Suspect drugs
 % Antibiotics 45% 32% 14% 37% 25%
 % Psychotropic 15% 17% 10% 7% 22%
 % HDS products 9% 0% 17.1% 16% 0%
 % Hypolipidemic 3% 3% 0% 3% 13%

NA= Not available