Table 2.

Study drug exposure and compliance (safety population)

Drug ComplianceEPPIC-1 (n=1016)EPPIC-2 (n=1012)Pooled (n=2028)
AST-120 
(n=507)Placebo 
(n=509)AST-120 
(n=507)Placebo 
(n=505)AST-120 
(n=1014)Placebo 
(n=1014)
Compliance, %a
 n5035025054961008998
 Mean±SD91.4±13.990.5±15.090.3±14.490.6±15.590.8±14.290.6±15.3
 Median96.196.195.496.495.896.2
 Minimum, maximum10.0, 120.06.2, 114.97.8, 119.33.4, 200.07.8, 120.03.4, 200.0
Categorical summary, n (%)
 <33%4 (0.8)4 (0.8)4 (0.8)5 (1.0)8 (0.8)9 (0.9)
≥33% to <50%9 (1.8)14 (2.8)12 (2.4)10 (2.0)21 (2.1)24 (2.4)
≥50% to <67%20 (4.0)29 (5.8)24 (4.8)22 (4.4)44 (4.4)51 (5.1)
≥67% to <83%41 (8.2)40 (8.0)49 (9.7)59 (11.9)90 (8.9)99 (9.9)
≥83% to <100%356 (70.8)349 (69.5)366 (72.5)329 (66.3)722 (71.6)678 (67.9)
≥100% to <110%71 (14.1)65 (12.9)47 (9.3)69 (13.9)118 (11.7)134 (13.4)
≥110%2 (0.4)1 (0.2)3 (0.6)2 (0.4)5 (0.5)3 (0.3)
 Total5035025054961008998
Duration of treatment, wkb
n50750950750510141014
 Mean±SD91.0±50.392.6±52.694.1±49.987.8±50.692.5±50.190.2±51.6
 Median102.1103.396.391.698.095.86
 Minimum, maximum0.1, 206.90.3, 207.30.4, 210.40.0, 206.00.1, 210.40.0, 207.3
Categorical summary, wk, n (%)
 <2465 (12.8)71 (13.9)57 (11.2)72 (14.3)122 (12.0)143 (14.1)
 ≥24 to <4868 (13.4)63 (12.4)56 (11.0)55 (10.9)124 (12.2)118 (11.6)
 ≥48 to <7250 (9.9)51 (10.0)48 (9.5)70 (13.9)98 (9.7)121 (11.9)
 ≥72 to <9648 (9.5)45 (8.8)91 (17.9)81 (16.0)139 (13.7)126 (12.4)
 ≥96 to <120117 (23.1)104 (20.4)93 (18.3)82 (16.2)210 (20.7)186 (18.3)
 ≥120 to <14484 (16.6)89 (17.5)74 (14.6)70 (13.9)158 (15.6)159 (15.7)
 ≥144 to <16848 (9.5)52 (10.2)49 (9.7)42 (8.3)97 (9.6)94 (9.3)
 ≥16827 (5.3)34 (6.7)39 (7.7)33 (6.5)66 (6.5)67 (6.6)
 Total50750950750510141014
  • Patients received a study medication kit every 3 months that consisted of 94 bottles of study medication (30 capsules of study medication per bottle). To evaluate study medication compliance, patients were asked to return all bottles (used and unused). Site personnel counted the remaining capsules to calculate the compliance rate. Results were similar in the ITT population.

  • a (Total dose taken/total dose required)×100.

  • b [(Date of last dose)–(date of first dose)+1]/7.