Study population Study settings Treatment ADRs Incidence of ADRs Drugs associated with ADRs Ref. no. 113 patients, 97 (85.8%) men Germany Stavudine/didanosine-based (
(64.6%)) Hepatic mitochondrial toxicity Stavudine and didanosine [5 ] 122 patients, 90 (73.8%) men Germany Zidovudine, lamivudine, abacavir, tenofovir Hepatotoxicity 1 (0.8%) case Tenofovir [6 ] 600 adults, 430 (71.7%) women Uganda Zidovudine, lamivudine, abacavir (
(50.0%)) Zidovudine, lamivudine, nevirapine (
(50.0%)) Grade 4 liver function test abnormalities (ALT or/and AST raised >10 times over the upper limit of normal), including acute hepatitis/hepatic failure Zidovudine Lamivudine Nevirapine [7 ] 133 pregnant women Brazil Nevirapine-based Grade ≤3 hepatotoxicity (ALT or/and AST raised ≤5 times over the upper limit of normal) 6 (4.5%) cases Nevirapine [8 ] Skin rash 21 (15.8%) cases Nevirapine 409 patients Thailand Zidovudine, lamivudine, nevirapine Stavudine, lamivudine, nevirapine Hepatotoxicity, including asymptomatic hepatitis, symptomatic hepatitis or hepatitis occurring concomitant with rash 64 (15.6%) cases, including 19 (4.6%) symptomatic cases Likely nevirapine [9 ] Rash 66 (16.1%) cases, including 21 (5.1%) grade 4 cases Nevirapine SJS 6 (1.5%) cases Nevirapine 142 patients: 105 (73.9%) men, Spain Nevirapine-based Zidovudine, lamivudine (
(45.8%)) Stavudine, lamivudine (
(23.9%)) Stavudine, didanosine (
(23.2%)) Other combinations (
(7.0%)) Hepatotoxicity (ALT or/and AST raised >5 times over the upper limit of normal) Clinical hepatitis (ALT or/and AST raised >5 times over the upper limit of normal and/or nausea, asthenia, jaundice) 8 (5.63%) cases Nevirapine [10 ] Skin rash 16 (11.27%) cases Nevirapine 157 pregnant women Brazil Zidovudine, lamivudine, nevirapine Grade ≤3 hepatotoxicity 7 (4.4%) cases Nevirapine [11 ] Skin rash 24 (15.3%) cases Nevirapine 540 patients Niger Stavudine, lamivudine, nevirapine Grade ≤3 hepatotoxicity (ALT or/and AST raised ≤5 times over the upper limit of normal) 78 (15.7%) cases, including 6 (1.2%) grade 3 cases Nevirapine [12 ] Cutaneous ADRs 7 (1.3%) cases, including 5 (0.9%) rash cases and 2 (0.4%) pruritus cases Nevirapine 315 children median age 7.2 years: 158 (50.2%) girls Rwanda Stavudine, lamivudine, nevirapine (
(89.2%)). Stavudine, lamivudine, efavirenz (
(1.9%)) Zidovudine, lamivudine, nevirapine (
(6.0%)). Zidovudine, lamivudine, efavirenz (
(2.9%)) Severe hepatotoxicity, including asymptomatic hepatitis, symptomatic hepatitis, and clinical hepatitis 5 (1.7% of 300 nevirapine patients) cases before month 3, including 4 clinical hepatitis cases and 1 grade 3 asymptomatic case 3 (1.0% of 300 nevirapine patients) symptomatic hepatitis cases after a mean 9 months Nevirapine [13 ] Grade ≥3 skin manifestations, including SJS 16 (5.3% of 300 nevirapine patients) cases, including 2 (0.7%) SJS cases Nevirapine 8736 patient records Tanzania Various combinations Liver toxicity Nevirapine Efavirenz [14 ] Skin rash Higher in nevirapine patients than in efavirenz patients Nevirapine Efavirenz 253 women, 42 (16.6%) pregnant United States Nevirapine-based Zidovudine/lamivudine most common NRTI backbone Hepatitis, including late-onset hepatitis 3 (1.2%) cases Nevirapine [15 ] Rash with concomitant hepatitis 2 (0.8%) cases Nevirapine Grade 1 rash 1 (0.4%) case Nevirapine 1110 patients, 631 (56.8%) men Argentina Nevirapine-based Hepatotoxicity (ALT or/and AST raised >5 times over the upper limit of normal for patients with previously normal levels or >3.5 times over the baseline level for patients with abnormal basal levels) 35 (3.2%) cases Nevirapine [16 ] Severe rash 49 (4.4%) cases Nevirapine 290 women, 125 (43.1%) pregnant Côte d’Ivoire Zidovudine, lamivudine, nevirapine (
(91.4%)). Stavudine, lamivudine, nevirapine (
(8.6%)) Hepatotoxicity (ALT or/and AST raised >5 times over the upper limit of normal) 10 (3.4%) cases Not specified [17 ] Rash 15 (5.2%) cases Likely nevirapine 2190 adults, 1567 (71.5%) women Rwanda Stavudine, lamivudine, nevirapine Hepatotoxicity (assessed based on ALT levels) 29 (1.3% of entire sample and 21.0% of 138 patients who stopped treatment due to nevirapine toxicity) cases Nevirapine [18 ] Skin rash 108 (4.9% of entire sample and 78.3% of 138 patients who stopped treatment due to nevirapine toxicity) cases Nevirapine 546 patients, 378 (69.2%) men Peru Lamivudine with either zidovudine (76% of cases), stavudine, or didanosine. Other drugs were nevirapine (
(57.5%)), efavirenz (
(38.5%)), lopinavir/ritonavir (
(3.5%)), atazanavir/ritonavir (
(0.4%)), or indinavir (
(0.2%)) Hepatotoxicity 7 (2.3%) cases Not specified [19 ] Rash 13 (2.4%) cases Likely nevirapine or efavirenz 765 patients: 614 (80.3%) men, 311 (40.6%) white, 265 (34.6%) black, 161 (21.0%) Hispanic United States Zidovudine, lamivudine, efavirenz (
(49.7%)). Zidovudine, lamivudine, abacavir, efavirenz (
(48.8%)) Grade 4 hepatotoxicity (ALT or/and AST, total bilirubin, direct bilirubin, alkaline phosphatase, γ -glutamyl transpeptidase raised >10 times over the upper limit of normal) 3 (4.3% of 70 patients who substituted efavirenz with nevirapine due to efavirenz toxicity) cases Nevirapine [20 ] Skin symptoms 18 (2.4%) cases 5 (33.3% of 15 patients who substituted efavirenz with nevirapine due to efavirenz toxicity) cases Efavirenz Nevirapine 103 pregnant women: 38 (36.9%) Caucasian, 24 (23.3%) Aboriginal Canada Nevirapine-based (
(54.4%)) Grade 4 hepatotoxicity (ALT or/and AST raised >10 times over the upper limit of normal) 1 (1.1% of 92 HAART-treated pregnancies) cases Nevirapine [21 ] Grade 3 hyperbilirubinemia (bilirubin raised 3–10 times over the upper limit of normal) 2 (2.2% of 92 HAART-treated pregnancies) cases Likely nevirapine Grade 2 rash and fever 2 (2.2% of 92 HAART-treated pregnancies) cases Nevirapine Grade 4 rash 1 (1.1% of 92 HAART-treated pregnancies) cases Nevirapine 137 patients, 103 (75.2%) men Spain Didanosine, stavudine, nelfinavir (
(48.9%)). Didanosine, stavudine, nevirapine (
(51.1%)) Hepatotoxicity Nelfinavir Nevirapine [22 ] Skin rash Nelfinavir Nevirapine GI ADRs (mainly diarrhea) 12 (14.9% of 67 nelfinavir patients and 2.8% of 70 nevirapine patients) cases Nelfinavir Nevirapine 573 patients, 366 (63.9%) men Italy Nevirapine-based 213 (37.2%) were taking zidovudine. 289 (50.4%) were taking stavudine. 71 (12.4%) were taking thymidine analogues. 97 (16.9%) were taking PIs Hepatotoxicity (increases in serum liver function tests), including grade 3 hepatotoxicity (ALT or/and AST raised >5 times over the upper limit of normal if baseline levels were normal or >3 times over the baseline level if this was higher than the upper limit of normal) 44 (22.3% of 197 toxicity-related treatment interruptions) cases, including 5 cases of grade 3 AST elevations and 11 cases of grade 3 ALT elevations Nevirapine and/or NRTIs [23 ] Cutaneous reactions 84 (42.6% of 197 toxicity-related treatment interruptions) cases Nevirapine Unspecified GI ADRs 10 (5.1% of 197 toxicity-related treatment interruptions) cases Nevirapine and/or NRTIs 1318 patients, 967 (73.4%) men Switzerland Tenofovir, emtricitabine, atazanavir/ritonavir (
(10.9%)). Tenofovir, emtricitabine, efavirenz (
(28.4%)). Tenofovir, emtricitabine, lopinavir/ritonavir (
(16.4%)). Tenofovir, emtricitabine, nevirapine (
(3.8%)). Zidovudine, lamivudine, efavirenz (
(5.8%)). Zidovudine, lamivudine, lopinavir/ritonavir (
(15.5%)). Abacavir, lamivudine, efavirenz (
(5.8%)) Hepatic events 152 (11.5%) cases, including 42 (29.2%) of 144 atazanavir/ritonavir patients Atazanavir/ritonavir (OR 2.55, 95% CI 1.01–6.42,
) Other drugs [24 ] HSR 38 (18.3% of 208 treatment interruptions due to drug toxicity) cases Nevirapine (OR 3.33, 95% CI 1.43–7.77,
) Atazanavir/ritonavir GI tract intolerance 60 (28.9% of 208 treatment interruptions due to drug toxicity and 14.2% of 424 lopinavir/ritonavir patients) cases Lopinavir/ritonavir (OR 5.50, 95% CI 2.67–11.3,
) 650 patients, 451 (69.4%) women Botswana Zidovudine/lamivudine, zidovudine/didanosine, or stavudine/lamivudine. 325 (50.0%) were taking nevirapine and 325 (50.0%) were taking efavirenz Hepatotoxicity 11 (3.4% of 325 nevirapine patients) cases Nevirapine [25 ] Cutaneous HSR 19 (5.8% of 325 nevirapine patients) cases Nevirapine Pancreatitis 10 (3.3% of 325 nevirapine patients) cases Likely nevirapine 188 patients, 150 (79.8%) men Spain Efavirenz-based (
(62.2%)). Lopinavir/ritonavir-based (
(37.8%)) Hepatotoxicity 8 (5.1% of 117 efavirenz patients and 2.8% of 71 lopinavir/ritonavir patients) cases Efavirenz Lopinavir/ritonavir [26 ] Diarrhea 1 (0.9% of 117 efavirenz patients) case Lopinavir/ritonavir Efavirenz 2233 children United States Zidovudine, lamivudine (
(59.8%)). Zidovudine, didanosine (
(45.8%)). Stavudine, lamivudine (
(51.7%)). Stavudine, didanosine (
(34.6%)). Didanosine, lamivudine (
(11.6%)) Hepatitis 56 (1.6% of 1336 zidovudine/lamivudine patients, 1.6% of 1022 zidovudine/didanosine patients, 1.6% of 1154 stavudine/lamivudine patients) cases Zidovudine and lamivudine Zidovudine and didanosine Stavudine and lamivudine [27 ] Bilirubin elevations 11 (0.5%) cases Stavudine and lamivudine Stavudine and didanosine Lamivudine and didanosine Zidovudine and lamivudine Zidovudine and didanosine Pancreatitis (assessed by routine monitoring of total amylase levels) 13 (1.7% of 772 stavudine/didanosine patients) cases Stavudine and didanosine 33 pregnant women: 20 (60.6%) Hispanic, 9 (27.3%) black, 4 (12.1%) white United States Zidovudine, lamivudine, nelfinavir Grade ≤3 elevated AST and γ -glutamyl transpeptidase 2 (6.1%) cases Treatment-related [28 ] 289 patients: 204 (70.6%) men, 280 (96.9%) white Spain Nevirapine-based Grade ≤3 elevated ALT/AST 6 (2.1%) cases Nevirapine and hepatitis A virus coinfection [29 ] 169 patients, 113 (66.9%) women Cameroon Zidovudine, lamivudine, nevirapine (
(50.3%)). Stavudine, lamivudine, nevirapine (
(49.7%)) Increases in ALT activity 1 (1.2% of 84 stavudine patients) case Stavudine [30 ] Rash 2 (1.2%) cases Zidovudine and stavudine 612 women: 443 (72.4%) black, 111 (18.1%) white, 53 (8.7) Hispanic United States Nevirapine-based (
(24.8%)). Nonnevirapine-based (
(75.2%)) Grade ≥2 liver enzyme elevations (graded according to the Toxicity Tables of the Division of Acquired Immunodeficiency Syndrome) 27 (4.4%) cases Nevirapine and/or other drugs [31 ] Grade ≥2 rash (graded according to the Toxicity Tables of the Division of Acquired Immunodeficiency Syndrome) 30 (5.7% of 526 patients included in the rash analysis and 26.3% of 114 patients who developed a new rash after therapy initiation) cases Nevirapine and/or other drugs SJS 1 (0.6% of 152 nevirapine patients) Nevirapine 88 children mean age 10.2 years: 51 (58.0%) girls, 38 (43.2%) white, 26 (29.5%) black Switzerland Lopinavir/ritonavir-based AST elevation (185 IU/L) 1 (1.1%) case Lopinavir/ritonavir [32 ] HSR Lopinavir/ritonavir GI toxicity, including hepatic and pancreatic symptoms 5 (5.7%) cases Lopinavir/ritonavir Amylase elevation without serum lipase elevation (870 IU/mL) 1 (1.1%) case Lopinavir/ritonavir 883 patients, 606 (68.6%) men Worldwide Tenofovir, emtricitabine, atazanavir/ritonavir (
(49.8%)). Tenofovir, emtricitabine, lopinavir/ritonavir (
(50.2%)) Grade ≥3 increases in ALT/AST 25 (3.9% of 435 atazanavir/ritonavir patients and 1.8% of 431 lopinavir/ritonavir patients) cases Atazanavir/ritonavir Lopinavir/ritonavir [33 ] Grade ≥3 increases in total bilirubin levels 146 (33.6% of 435 atazanavir/ritonavir patients) cases Mainly atazanavir/ ritonavir Jaundice No mention of Gilbert syndrome or hemolysis 3 (0.7% of 440 atazanavir/ritonavir patients) cases Atazanavir/ritonavir Diarrhea and grade ≥2 nausea 4 (0.9% of 443 lopinavir/ritonavir patients) cases Lopinavir/ritonavir 40 patients, 20 (50.0%) women Uganda Zidovudine, didanosine, lopinavir/ritonavir (
(90.0%)). Stavudine, didanosine, lopinavir/ritonavir (
(10.0%)) Elevated AST levels 2 (5.0%) cases Not specified [34 ] Nausea or vomiting 7 (17.5%) cases Didanosine and unspecified drugs Diarrhea 9 (22.5%) cases Not specified 49 children, 30 (61.2%) boys Burkina Faso Didanosine, lamivudine, efavirenz Increases in liver enzyme levels 2 (4.1%) cases Likely didanosine [35 ] Increases in pancreatic enzyme levels without pancreatitis 1 (2.0%) case Likely didanosine 3333 patients England Not specified Jaundice No mention of Gilbert syndrome or hemolysis 7 (3.4% of 203 treatment switches) cases Atazanavir [36 ] Suspected/actual HSR 5 (2.5% of 203 treatment switches and 62.5% of 8 treatment switches due to abacavir toxicity) cases Abacavir Unspecified GI side effects 9 (4.4% of 203 treatment switches and 100% of 9 treatment switches due to saquinavir toxicity) cases Saquinavir Diarrhea 7 (3.4% of 203 treatment switches) cases Lopinavir/ritonavir 158 patients, 104 (65.8%) men Italy Tenofovir, emtricitabine, efavirenz (
(25.9%)). Tenofovir, emtricitabine, various boosted PIs (
(29.1%)). Abacavir, lamivudine, efavirenz (
(7.6%)). Abacavir, lamivudine, various boosted PIs (
(25.9%)). Other combinations including boosted PIs (
(11.4%)) Early HSR 2 (3.8% among 53 abacavir patients) cases Abacavir [37 ] 56 patients: 49 (87.5%) men, 26 (46.4%) white, 18 (32.1%) black United States Tenofovir, another NRTI, lopinavir/ritonavir, fosamprenavir (
(50.0%)). Tenofovir, other NRTIs, lopinavir/ritonavir (
(25.0%)). Tenofovir, other NRTIs, fosamprenavir/ritonavir (
(25.0%)) HSR Abacavir [38 ] 600 patients, 430 (71.7%) women Uganda Zidovudine, lamivudine plus either abacavir or nevirapine Suspected HSR (grade ≤3) 15 (3.0% of 300 nevirapine patients and 2.0% of 300 abacavir patients) cases Nevirapine Abacavir [39 ] Suspected HSR (grade 4) 4 (1.3% of 300 nevirapine patients) cases Nevirapine 357 HLA B*5701-negative adults: 348 (97.5%) men, 307 (86%) white Australia Tenofovir and emtricitabine, or abacavir and lamivudine. Other drugs included zidovudine, didanosine, stavudine, atazanavir, lopinavir, efavirenz or nevirapine HSR Abacavir [40 ] 385 HLA-B*5701-negative adults 313 (81.3%), men 56 (14.5%) black Europe Abacavir, lamivudine, efavirenz. Tenofovir, emtricitabine, efavirenz HSR Abacavir [41 ] 211 children mean age 5 years: 111 (52.6%) boys Zambia Stavudine, lamivudine, nevirapine Grade ≤2 rash 15 (7.1% of 211 nevirapine patients and 37.5% of 40 ADRs judged to be definitely/probably related to nevirapine) cases Nevirapine [42 ] 57 patients, 39 (68.4%) men China Stavudine, didanosine, nevirapine (
(66.7%)). Stavudine, lamivudine, nevirapine (
(17.5%)). Zidovudine, lamivudine, nevirapine (
(15.8%)) Rash (including grade 3 rash) 3 (5.3%) cases Likely nevirapine [43 ] 173 adults, 107 (61.8%) men Cambodia Efavirenz was substituted with nevirapine Cutaneous HSR 10 (5.8% of 173 patients substituting efavirenz with nevirapine and 52.6% of 19 patients who developed nevirapine-induced treatment-limiting HSRs) cases Nevirapine [44 ] Hepatic HSR 10 (5.2% of 173 patients substituting efavirenz with nevirapine and 47.4% of 19 patients who developed nevirapine-induced treatment-limiting HSRs) cases Nevirapine 394 patients, 263 (66.8%) men Cambodia Stavudine, lamivudine, nevirapine Minor rash 17 (4.3% of 394 patients who switched efavirenz with full-dose nevirapine and 32.7% of 52 cases of nevirapine-induced ADRs) cases 49 (7.4% of 661 ART-naive patients commencing nevirapine-based HAART and 51.6% of 95 cases of nevirapine-induced ADRs) cases Nevirapine [45 ] Severe HSR, including severe rash, SJS, TEN and/or hepatitis 35 (8.9% of 394 patients who switched efavirenz with full-dose nevirapine and 67.3% of 52 cases of nevirapine-induced ADRs) cases, including 30 cases of severe rash, 2 cases of SJS, and 3 cases of grade ≥3 hepatitis. 44 (6.6% of 661 ART-naive patients commencing nevirapine-based HAART and 46.3% of 95 cases of nevirapine-induced ADRs) cases, including 36 cases of severe rash (one fatal), 2 cases of SJS (one fatal), one case of fatal TEN, and 5 cases of grade ≥3 hepatitis Nevirapine Grade ≤4 hepatitis Nevirapine 121 adolescents mean age 7 years: 70 (57.8%) boys Jamaica 77 (63.6%) receiving HAART Zidovudine/lamivudine-based (
(93.5%)). Nevirapine-based (
(93.5%)). Zidovudine, lamivudine, nevirapine (
(87.0%)) HSR 3 (4.2% of 72 nevirapine patients and 3.9% of 77 HAART patients) cases Nevirapine [46 ] Nausea and vomiting Either zidovudine, lamivudine and/or nevirapine 10186 patients: 7395 (72.6%) men, 6227 (61.1%) Caucasian Europe and Canada Nevirapine-based (
) Zidovudine, lamivudine, nevirapine (
(45.4%)) Hepatotoxicity without concomitant skin rash 124 (1.9% of 4620 nevirapine patients and 27.1% of 458 patients who interrupted nevirapine due to HSRs) cases Nevirapine [47 ] Skin rash 334 (5.1% of 4620 nevirapine patients and 72.9% of 458 patients who interrupted nevirapine due to HSRs) cases Nevirapine Unspecified GI symptoms 402 (6.14% of 4620 nevirapine patients) cases Nevirapine and/or NRTIs Unspecified pancreas-related toxicities 4 cases among nevirapine patients Nevirapine and/or NRTIs 217 patients, 122 (56.2%) men Senegal Didanosine, lamivudine, efavirenz (
(29.0%)). Stavudine, didanosine, efavirenz (
(20.3%)). Stavudine, lamivudine, efavirenz (
(5.7%)). Zidovudine, lamivudine, efavirenz (
(24.0%)). Lamivudine, zidovudine, nevirapine (
(12.9%)). Didanosine, lamivudine, nevirapine (
(3.7%)). Stavudine, didanosine, nevirapine (
(3.7%)). Stavudine, lamivudine, nevirapine (
(1.4%)) Hepatitis, including hepatitis with concurrent skin rash 3 (6.4% of 47 nevirapine patients) cases, including 2 (4.2%) cases with concurrent skin rash Nevirapine [48 ] Skin rash, including SJS and TEN 3 (6.4% of 47 nevirapine patients) cases, including 2 (4.2%) cases of SJS or TEN Nevirapine Hyperamylasemia 10 (4.6%) cases Likely efavirenz or nevirapine 230 adults, 172 (74.8%) men India Stavudine, lamivudine, nevirapine (
(68.3%)). Stavudine, lamivudine, efavirenz (
(7.8%)). Zidovudine, lamivudine, nevirapine (
(17.8%)). Zidovudine, lamivudine, efavirenz (
(6.1%)) Severe rash (SJS or TEN) 9 (3.9%) cases, including 1 (0.4%) case of fatal TEN Likely nevirapine or efavirenz [49 ] 126 patients, 109 (86.5%) men Spain and Italy Lamivudine, abacavir, efavirenz (
(50.0%)). Lamivudine, abacavir, lopinavir/ritonavir (
(50.0%)) HSR/rash 8 (6.3%) cases Efavirenz Lopinavir/ritonavir [50 ] 21 Caucasian patients, 16 (76.2%) men France Efavirenz-based (
(33.3%))
(66.7%)) HSR 6 (28.6%) cases Efavirenz Nevirapine [51 ] 650 adults, 451 (69.4%) women Botswana Either zidovudine and lamivudine, zidovudine and didanosine, or stavudine and lamivudine, plus either nevirapine or efavirenz SJS 16 (2.5%) cases Likely nevirapine or efavirenz [52 ] 66 patients, 56 (84.8%) men Spain Lopinavir/ritonavir-based (
(50.0%)). Nevirapine-based (
(50.0%)). NRTIs were didanosine, stavudine, and/or zidovudine Diarrhea 10 (15.2%) cases Likely nevirapine or lopinavir/ritonavir [53 ] 70 patients, 50 (71.4%) men Spain Lopinavir/ritonavir-based Unspecified GI symptoms assessed using the Gastrointestinal Symptom Rating Scale 1 (1.4%) case Lopinavir/ritonavir [54 ] 23 patients, 18 (78.3%) men Spain Zidovudine, lamivudine, abacavir, tenofovir Unspecified GI symptoms Lopinavir/ritonavir, tipranavir [55 ] 115 patients, 70 (60.9%) men France Indinavir/ritonavir-based Lopinavir/ritonavir-based Nelfinavir-based Unspecified GI ADRs 4 (12.5% among 32 lopinavir/ritonavir patients) cases Lopinavir/Ritonavir [56 ] Diarrhea 1 (3.2% among 32 nelfinavir patients) case Nelfinavir 1771 patients, 1204 (68.0%) men South Africa Zidovudine, didanosine, efavirenz (
(25.1%)). Stavudine, lamivudine, efavirenz (
(25.1%)). Zidovudine, didanosine, lopinavir/ritonavir (
(24.8%)). Stavudine, lamivudine, lopinavir/ritonavir (
(25.0%)) Nausea, constipation, fatigue Zidovudine and didanosine. Stavudine and lamivudine [57 ] 630 patients, 494 (78.4%) men Worldwide Saquinavir/ritonavir-based (
(49.0%)). Lopinavir/ritonavir-based (
(25.9%)). Indinavir/ritonavir-based (
(25.1%)) Unspecified GI toxicity, including grade ≥3 GI ADRs Saquinavir [58 ] 12 patients: 11 (91.7%) men, 9 (75.0%) Caucasian, 3 (25.0%) black United Kingdom Saquinavir/ritonavir-based Mild nausea and diarrhea 5 (41.7%) cases Likely treatment-related [59 ] 1081 patients, 708 (65.5%) men Italy Not specified Pancreatic toxicity (at least 3-fold increases in serum pancreatic enzymes) 166 (38.2% of 435 patients with confirmed laboratory pancreatic abnormalities) cases Concurrent use of didanosine, stavudine, lamivudine [60 ]
