Trial Outcomes & Findings for Drug Use Investigation of Kaletra (NCT NCT01076972)

NCT ID: NCT01076972

Last Updated: 2012-03-01

Results Overview

Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.

• Recruitment status: COMPLETED
• Target enrollment: 1184 participants
• Primary outcome timeframe: During the course of the survey period up to Year 8
• Results posted on: 2012-03-01

Participant Flow

Participant milestones

Measure	Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
Overall Study STARTED	1184
Overall Study COMPLETED	1184
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug Use Investigation of Kaletra

Baseline characteristics by cohort

Measure	Lopinavir/Ritonavir Group n=1184 Participants All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
Age Continuous	39.7 years STANDARD_DEVIATION 11.0 • n=5 Participants
Age, Customized <=14 years	4 participants n=5 Participants
Age, Customized Between 15 and 64 years	1155 participants n=5 Participants
Age, Customized >=65 years	25 participants n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants
Sex: Female, Male Male	1078 Participants n=5 Participants
Region of Enrollment Japan	1184 participants n=5 Participants

PRIMARY outcome

Timeframe: During the course of the survey period up to Year 8

Population: Available data for all patients were included.

Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.

Outcome measures

Measure	Lopinavir/Ritonavir Group n=1184 Participants All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.	Lopinavir/Ritonavir: Treatment-Experienced The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.	Lopinavir/Ritonavir: Baseline Category C The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-0 The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-1 The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-2 The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category Unknown The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
Total Number of Patients With Adverse Drug Reactions Any adverse drug reaction	649 participants	—	—	—	—	—	—
Total Number of Patients With Adverse Drug Reactions Hypertriglyceridaemia	67 participants	—	—	—	—	—	—
Total Number of Patients With Adverse Drug Reactions Hyperlipidaemia	211 participants	—	—	—	—	—	—
Total Number of Patients With Adverse Drug Reactions Diarrhoea	130 participants	—	—	—	—	—	—
Total Number of Patients With Adverse Drug Reactions Nausea	72 participants	—	—	—	—	—	—
Total Number of Patients With Adverse Drug Reactions Blood triglycerides increased	99 participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period

Population: Available data at each visit for each subgroup of patients who had not received and received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline or treatment data were missing for a given visit were excluded from the analysis for that visit.

The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.

Outcome measures

Measure	Lopinavir/Ritonavir Group n=416 Participants All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.	Lopinavir/Ritonavir: Treatment-Experienced n=420 Participants The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.	Lopinavir/Ritonavir: Baseline Category C The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-0 The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-1 The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-2 The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category Unknown The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
Cluster of Differentiation 4 Lymphocyte Count (CD4) Baseline (Month 0 [n = 416, 420])	125.0 cells per cubic millimeter Standard Deviation 123.5	290.6 cells per cubic millimeter Standard Deviation 224.6	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Month 3 (n = 315, 283)	257.2 cells per cubic millimeter Standard Deviation 170.8	342.9 cells per cubic millimeter Standard Deviation 230.5	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Month 6 (n = 288, 252)	275.9 cells per cubic millimeter Standard Deviation 175.4	366.4 cells per cubic millimeter Standard Deviation 227.0	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Month 9 (n = 223, 238)	311.1 cells per cubic millimeter Standard Deviation 175.1	385.0 cells per cubic millimeter Standard Deviation 224.3	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Month 12 (Year 1 [n = 201, 233])	329.9 cells per cubic millimeter Standard Deviation 178.6	410.4 cells per cubic millimeter Standard Deviation 214.7	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Year 2 (n = 146, 190)	419.4 cells per cubic millimeter Standard Deviation 201.1	437.4 cells per cubic millimeter Standard Deviation 224.2	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Year 3 (n = 106, 150)	455.6 cells per cubic millimeter Standard Deviation 202.4	481.5 cells per cubic millimeter Standard Deviation 255.4	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Year 4 (n = 69, 99)	475.2 cells per cubic millimeter Standard Deviation 209.6	526.6 cells per cubic millimeter Standard Deviation 296.4	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Year 5 (n = 40, 73)	535.1 cells per cubic millimeter Standard Deviation 248.0	496.2 cells per cubic millimeter Standard Deviation 228.7	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Year 6 (n = 25, 42)	577.1 cells per cubic millimeter Standard Deviation 241.9	569.7 cells per cubic millimeter Standard Deviation 287.0	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Year 7 (n = 3, 17)	602.0 cells per cubic millimeter Standard Deviation 156.1	597.7 cells per cubic millimeter Standard Deviation 224.2	—	—	—	—	—
Cluster of Differentiation 4 Lymphocyte Count (CD4) Year 8 (n = 0, 3)	NA cells per cubic millimeter Standard Deviation NA No data were recorded for any patients at this visit.	493.7 cells per cubic millimeter Standard Deviation 414.8	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period

Population: Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.

Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.

Outcome measures

Measure	Lopinavir/Ritonavir Group n=416 Participants All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.	Lopinavir/Ritonavir: Treatment-Experienced n=418 Participants The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.	Lopinavir/Ritonavir: Baseline Category C The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-0 The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-1 The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-2 The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category Unknown The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Baseline (Month 0 [n = 416, 418])	4.9 copies/mL Standard Deviation 0.8	3.5 copies/mL Standard Deviation 1.1	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Month 3 (n = 315, 280)	2.7 copies/mL Standard Deviation 0.4	2.8 copies/mL Standard Deviation 0.5	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Month 6 (n = 288, 253)	2.7 copies/mL Standard Deviation 0.3	2.8 copies/mL Standard Deviation 0.6	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Month 9 (n = 224, 238)	2.6 copies/mL Standard Deviation 0.3	2.8 copies/mL Standard Deviation 0.5	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Month 12 (Year 1 [n = 203, 230])	2.7 copies/mL Standard Deviation 0.4	2.8 copies/mL Standard Deviation 0.6	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Year 2 (n = 145, 190)	2.7 copies/mL Standard Deviation 0.3	2.7 copies/mL Standard Deviation 0.5	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Year 3 (n = 107, 147)	2.6 copies/mL Standard Deviation 0.1	2.7 copies/mL Standard Deviation 0.4	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Year 4 (n = 70, 99)	2.6 copies/mL Standard Deviation 0.1	2.7 copies/mL Standard Deviation 0.4	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Year 5 (n = 39, 72)	2.7 copies/mL Standard Deviation 0.3	2.8 copies/mL Standard Deviation 0.5	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Year 6 (n = 25, 41)	2.7 copies/mL Standard Deviation 0.3	2.6 copies/mL Standard Deviation 0.3	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Year 7 (n = 3, 17)	2.6 copies/mL Standard Deviation 0.0	2.8 copies/mL Standard Deviation 0.6	—	—	—	—	—
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit Year 8 (n = 0, 3)	NA copies/mL Standard Deviation NA No data were recorded for any patients at this visit.	2.6 copies/mL Standard Deviation 0.0	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Month 0) and following last treatment dose during the course of the survey period

Population: Available data for all patients were included.

Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).

Outcome measures

Measure	Lopinavir/Ritonavir Group n=378 Participants All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.	Lopinavir/Ritonavir: Treatment-Experienced n=71 Participants The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.	Lopinavir/Ritonavir: Baseline Category C n=323 Participants The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-0 The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-1 The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category P-2 n=1 Participants The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).	Lopinavir/Ritonavir: Baseline Category Unknown n=411 Participants The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents Category A after lopinavir/ritonavir treatment	206 participants	0 participants	0 participants	—	—	0 participants	103 participants
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents Category B after lopinavir/ritonavir treatment	2 participants	32 participants	0 participants	—	—	0 participants	22 participants
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents Category C after lopinavir/ritonavir treatment	6 participants	2 participants	191 participants	—	—	0 participants	86 participants
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents Category P-0 after lopinavir/ritonavir treatment	0 participants	0 participants	0 participants	—	—	0 participants	0 participants
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents Category P-1 after lopinavir/ritonavir treatment	0 participants	0 participants	0 participants	—	—	0 participants	1 participants
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents Category P-2 after lopinavir/ritonavir treatment	0 participants	0 participants	0 participants	—	—	0 participants	0 participants
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents Category unknown after treatment	164 participants	37 participants	132 participants	—	—	1 participants	199 participants

Adverse Events

Lopinavir/Ritonavir Group

Serious events: 189 serious events

Other events: 539 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lopinavir/Ritonavir Group n=1184 participants at risk All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
Infections and infestations Acute tonsillitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Amoebic dysentery	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Appendicitis	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Bronchitis	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Cellulitis	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Cryptosporidiosis infection	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Cytomegalovirus infection	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Disseminated tuberculosis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Gastroenteritis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Gastroenteritis salmonella	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Genital herpes	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Giardiasis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Hepatitis B	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Herpes zoster	0.84% 10/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Influenza	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Measles	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Meningitis cryptococcal	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Meningitis herpes	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Neurosyphilis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Oesophageal candidiasis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Oral candidiasis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Otitis media	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Pharyngitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Pneumonia	0.59% 7/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Pneumonia pneumococcal	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Progressive multifocal leukoencephalopathy	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Prostatic abscess	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Pyelonephritis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Septic shock	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Tonsillitis	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Cytomegalovirus chorioretinitis	0.34% 4/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations AIDS encephalopathy	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Staphylococcal sepsis	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Cerebral toxoplasmosis	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Staphylococcal infection	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Mycobacterium avium complex infection	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Anogenital warts	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Tuberculosis gastrointestinal	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Atypical mycobacterial infection	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Hepatic amoebiasis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Pneumocystis jiroveci pneumonia	0.42% 5/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Extrapulmonary tuberculosis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Enterocolitis bacterial	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Infections and infestations Oral herpes	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system lymphoma	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine carcinoma	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Anaemia	1.1% 13/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Febrile neutropenia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Iron deficiency anaemia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Leukopenia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Lymphadenitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Neutropenia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Pancytopenia	0.42% 5/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Thrombocytopenia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Blood and lymphatic system disorders Bone marrow failure	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Immune system disorders Behcet's syndrome	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Immune system disorders Hypersensitivity	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Immune system disorders Immune reconstitution syndrome	0.68% 8/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Endocrine disorders Adrenal insufficiency	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Endocrine disorders Hyperthyroidism	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Cachexia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Dehydration	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Diabetes mellitus	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Glucose tolerance impaired	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Hyperkalaemia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Hyperlactacidaemia	0.34% 4/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Hypoalbuminaemia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Hypokalaemia	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Lactic acidosis	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Malnutrition	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Decreased appetite	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Anxiety	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Depression	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Eating disorder	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Emotional disorder	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Hallucination, auditory	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Insomnia	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Mania	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Suicidal ideation	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Suicide attempt	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Psychiatric disorders Psychotic disorder	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Cerebral haemorrhage	0.34% 4/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Cerebral infarction	0.34% 4/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Convulsion	0.42% 5/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Encephalitis	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Epilepsy	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Guillain-Barre syndrome	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Hemiparesis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Hemiplegia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Hepatic encephalopathy	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Hypoaesthesia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Loss of consciousness	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Memory impairment	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Myelitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Neuropathy peripheral	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Paralysis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Status epilepticus	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Subarachnoid haemorrhage	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders Tremor	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Nervous system disorders VIIth nerve paralysis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Eye disorders Cataract	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Eye disorders Retinal detachment	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Eye disorders Ulcerative keratitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Acute myocardial infarction	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Arrhythmia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Atrioventricular block	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Atrioventricular block complete	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Bradycardia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Cardiac failure	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Cardiac failure congestive	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Conduction disorder	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Left ventricular failure	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Myocardial infarction	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Myocarditis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Palpitations	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Sinus arrest	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Sinus bradycardia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Cardiac disorders Tachycardia	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Vascular disorders Circulatory collapse	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Vascular disorders Hypertension	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Vascular disorders Kawasaki's disease	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Vascular disorders Deep vein thrombosis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Vascular disorders Intra-abdominal haematoma	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Acute abdomen	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Anorectal disorder	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Ascites	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Colitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Diarrhoea	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Duodenal ulcer	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Enterocolitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Gastric ulcer	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Ileus	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Intestinal obstruction	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Nausea	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Pancreatitis acute	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Pancreatitis relapsing	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Vomiting	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Subileus	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Cholecystitis acute	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Cholelithiasis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Hepatic cirrhosis	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Hepatic failure	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Hepatic function abnormal	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Hepatitis acute	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Hepatitis fulminant	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Jaundice	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Hepatobiliary disorders Liver disorder	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Skin and subcutaneous tissue disorders Drug eruption	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Skin and subcutaneous tissue disorders Erythema nodosum	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Skin and subcutaneous tissue disorders Rash	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Musculoskeletal and connective tissue disorders Arthralgia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Musculoskeletal and connective tissue disorders Osteomalacia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Musculoskeletal and connective tissue disorders Pain in extremity	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Renal and urinary disorders Calculus urinary	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Renal and urinary disorders Nephrotic syndrome	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Renal and urinary disorders Renal disorder	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Renal and urinary disorders Renal failure acute	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Renal and urinary disorders Renal failure chronic	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Renal and urinary disorders Urinary bladder haemorrhage	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Renal and urinary disorders Renal impairment	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Reproductive system and breast disorders Epididymitis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Congenital, familial and genetic disorders Fanconi syndrome	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
General disorders Death	0.17% 2/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
General disorders Necrosis	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
General disorders Pyrexia	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations C-reactive protein increased	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations Chest X-ray abnormal	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations Platelet count decreased	0.51% 6/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations Red blood cell count decreased	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations White blood cell count decreased	0.34% 4/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations Protein urine present	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations Transaminases increased	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Injury, poisoning and procedural complications Femoral neck fracture	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Injury, poisoning and procedural complications Fracture	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Injury, poisoning and procedural complications Intentional overdose	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Injury, poisoning and procedural complications Spinal compression fracture	0.08% 1/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Injury, poisoning and procedural complications Subdural haematoma	0.25% 3/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.

Other adverse events

Measure	Lopinavir/Ritonavir Group n=1184 participants at risk All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
Metabolism and nutrition disorders Hypertriglyceridaemia	6.5% 77/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Metabolism and nutrition disorders Hyperlipidaemia	19.4% 230/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Diarrhoea	12.5% 148/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Gastrointestinal disorders Nausea	7.3% 87/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.
Investigations Blood triglycerides increased	8.8% 104/1184 • During the course of the survey period up to Year 8. Adverse drug reactions (ADRs) for Primary Outcome Measure 1, defined as AEs (a) for which the causal relationship with Kaletra was other than 'not related' (including 'unclear') and (b) which occurred in \> 5% of patients, were summarized from the list of AEs below. ADRs are inclusive of all such events reported at each visit.

Additional Information

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• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
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