ER-NTX Baseline 0 / 74 0 / 52 0 / 126 Peak of (0.0) (0.0) (0.0) 11/103 (10.7) at Postbaseline 9 / 62 12 / 45 21 / 107 Wk 4. (14.5) (26.7) (19.6) NSDs for ER-NTX vs. PBO and for HIV– vs. HIV+ gps. PBO Baseline 0 / 70 0 / 54 0 / 124 Peak of 5 / (0.0) (0.0) (0.0) 81 (6.2) at Wk 4. Postbaseline 8 / 51 3 / 34 11 / 85 NSD for (15.7) (8.8) (12.9) HIV– vs. HIV+ gps. Aspartate aminotransferase 3 x ULN, n/N (%) ER-NTX Baseline 0 / 74 0 / 52 0 / 126 Peak of 9 / (0.0) (0.0) (0.0) 103 (8.7) at Wk 4. Postbaseline 2 / 62 13 / 45 15 / 107 NSDs for (3.2) (28.9) (14.0) ER-NTX vs. PBO and for HIV– vs. HIV+ gps PBO Baseline 0 / 70 0 / 54 0 / 124 Peak of 5 / (0.0) (0.0) (0.0) 81 (6.2) at Wk 4. Postbaseline 5 / 51 4 / 34 9 / 85 NSD (9.8) (11.8) (10.6) between and HIV+ gps. transferase 3 x ULN, n/N (%) ER-NTX Baseline 10 / 74 13 / 52 23 / 126 Highest % (13.5) (25) (18.3) was at BL. Postbaseline Postbaseline 11 / 62 14 / 45 25 / 107 peak of 18 / (17.7) (31.1) (23.4) 103 (17.5) at Wk 4. NSDs for ER-NTX vs. PBO and for
ER-NTX Baseline 0 / 74 (0.0) 0 / 52 (0.0) 0 / 126 (0.0) Peak of 11/103 (10.7) at Wk 4. NSDs for ER-NTX vs. PBO and for HIV– vs. HIV+ gps. Postbaseline 9 / 62 (14.5) 12 / 45 (26.7) 21 / 107 (19.6) PBO Baseline 0 / 70 (0.0) 0 / 54 (0.0) 0 / 124 (0.0) Peak of 5 / 81 (6.2) at Wk 4. NSD for HIV– vs. HIV+ gps. Postbaseline 8 / 51 (15.7) 3 / 34 (8.8) 11 / 85 (12.9) Aspartate aminotransferase 3 x ULN, n/N (%) ER-NTX Baseline 0 / 74 (0.0) 0 / 52 (0.0) 0 / 126 (0.0) Peak of 9 / 103 (8.7) at Wk 4. NSDs for ER-NTX vs. PBO and for HIV– vs. HIV+ gps Postbaseline 2 / 62 (3.2) 13 / 45 (28.9) 15 / 107 (14.0) PBO Baseline 0 / 70 (0.0) 0 / 54 (0.0) 0 / 124 (0.0) Peak of 5 / 81 (6.2) at Wk 4. NSD between and HIV+ gps. Postbaseline 5 / 51 (9.8) 4 / 34 (11.8) 9 / 85 (10.6) transferase 3 x ULN, n/N (%) ER-NTX Baseline 10 / 74 (13.5) 13 / 52 (25) 23 / 126 (18.3) Highest % was at BL. Postbaseline peak of 18 / 103 (17.5) at Wk 4. NSDs for ER-NTX vs. PBO and for Postbaseline 11 / 62 (17.7) 14 / 45 (31.1) 25 / 107 (23.4)
Naltrexone_ER_Susp_Inj_Monograph_Addendum_2014.docx