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This non-interventional, post-marketing observational study was conducted to obtain data, such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical practice and investigate the necessity to conduct a follow-up post-marketing clinical study in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir/ritonavir (Kaletra) | Drug | Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Patients With Adverse Drug Reactions | 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. | During the course of the survey period up to Year 8 |
| Cluster of Differentiation 4 Lymphocyte Count (CD4) | 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. | 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 |
| Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications according to the Package Insert:
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Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Yo Hoshino | Abbott Japan Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 36516 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 36517 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Patients With Adverse Drug Reactions | 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. | Available data for all patients were included. | Posted | Number | participants | During the course of the survey period up to Year 8 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute tonsillitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| C558899 | lopinavir-ritonavir drug combination |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents | 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). | Baseline (Month 0) and following last treatment dose during the course of the survey period |
| Aichi |
| Japan |
| Site Reference ID/Investigator# 36518 | Chiba | Japan |
| Site Reference ID/Investigator# 36519 | Fukuoka | Japan |
| Site Reference ID/Investigator# 36521 | Fukuoka | Japan |
| Site Reference ID/Investigator# 36522 | Hiroshima | Japan |
| Site Reference ID/Investigator# 36523 | Hokkaido | Japan |
| Site Reference ID/Investigator# 36524 | Hyōgo | Japan |
| Site Reference ID/Investigator# 36525 | Kanagawa | Japan |
| Site Reference ID/Investigator# 36526 | Kyoto | Japan |
| Site Reference ID/Investigator# 36622 | Miyagi | Japan |
| Site Reference ID/Investigator# 36623 | Miyagi | Japan |
| Site Reference ID/Investigator# 36624 | Niigata | Japan |
| Site Reference ID/Investigator# 36625 | Okayama | Japan |
| Site Reference ID/Investigator# 36626 | Osaka | Japan |
| Site Reference ID/Investigator# 36627 | Osaka | Japan |
| Site Reference ID/Investigator# 36628 | Shizuoka | Japan |
| Site Reference ID/Investigator# 36629 | Tokyo | Japan |
| Site Reference ID/Investigator# 36630 | Tokyo | Japan |
| Site Reference ID/Investigator# 36631 | Tokyo | Japan |
| Site Reference ID/Investigator# 36632 | Tokyo | Japan |
| Site Reference ID/Investigator# 36633 | Tokyo | Japan |
| Site Reference ID/Investigator# 36634 | Tokyo | Japan |
| Site Reference ID/Investigator# 36635 | Tokyo | Japan |
| Site Reference ID/Investigator# 36636 | Tokyo | Japan |
| Site Reference ID/Investigator# 36637 | Tokyo | Japan |
| Site Reference ID/Investigator# 36638 | Tokyo | Japan |
| Site Reference ID/Investigator# 36639 | Tokyo | Japan |
| Site Reference ID/Investigator# 5342 | Tokyo | Japan |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Cluster of Differentiation 4 Lymphocyte Count (CD4) | 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. | 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. | Posted | Mean | Standard Deviation | cells per cubic millimeter | 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 |
|
|
|
| Primary | Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each 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. | 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. | Posted | Mean | Standard Deviation | copies/mL | 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 |
|
|
|
| Primary | Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents | 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). | Available data for all patients were included. | Posted | Number | participants | Baseline (Month 0) and following last treatment dose during the course of the survey period |
|
|
|
| 189 |
| 1,184 |
| 539 |
| 1,184 |
| Amoebic dysentery | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cryptosporidiosis infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Giardiasis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Measles | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Meningitis cryptococcal | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Meningitis herpes | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Neurosyphilis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Prostatic abscess | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| AIDS encephalopathy | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Cerebral toxoplasmosis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Mycobacterium avium complex infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Tuberculosis gastrointestinal | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatic amoebiasis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Extrapulmonary tuberculosis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Enterocolitis bacterial | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
|
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Behcet's syndrome | Immune system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Immune reconstitution syndrome | Immune system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hyperlactacidaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Eating disorder | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Emotional disorder | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Myelitis | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Conduction disorder | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Myocarditis | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Intra-abdominal haematoma | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Hepatitis fulminant | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Osteomalacia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Epididymitis | Reproductive system and breast disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Fanconi syndrome | Congenital, familial and genetic disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Death | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Necrosis | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| Chest X-ray abnormal | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
|
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.
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| Month 6 (n = 288, 252) |
|
| Month 9 (n = 223, 238) |
|
| Month 12 (Year 1 [n = 201, 233]) |
|
| Year 2 (n = 146, 190) |
|
| Year 3 (n = 106, 150) |
|
| Year 4 (n = 69, 99) |
|
| Year 5 (n = 40, 73) |
|
| Year 6 (n = 25, 42) |
|
| Year 7 (n = 3, 17) |
|
| Year 8 (n = 0, 3) |
|
| Month 6 (n = 288, 253) |
|
| Month 9 (n = 224, 238) |
|
| Month 12 (Year 1 [n = 203, 230]) |
|
| Year 2 (n = 145, 190) |
|
| Year 3 (n = 107, 147) |
|
| Year 4 (n = 70, 99) |
|
| Year 5 (n = 39, 72) |
|
| Year 6 (n = 25, 41) |
|
| Year 7 (n = 3, 17) |
|
| Year 8 (n = 0, 3) |
|
| Category B after lopinavir/ritonavir treatment |
|
| Category C after lopinavir/ritonavir treatment |
|
| Category P-0 after lopinavir/ritonavir treatment |
|
| Category P-1 after lopinavir/ritonavir treatment |
|
| Category P-2 after lopinavir/ritonavir treatment |
|
| Category unknown after treatment |
|