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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
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To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death. | Baseline to 30 days post-week 96 or early termination (ET) |
| Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death. | Baseline to 30 days post-week 96 or ET |
| Number of Participants With Treatment Emergent Malignancies | Baseline to 30 days post-week 96 or ET | |
| Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System. | Baseline to 30 days post-week 96 or ET |
| Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT) | |
| Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]). | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Salvador | Estado de Bahia | 40110-160 | Brazil | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23731330 | Derived | Furtado J, Madruga JV, Bicudo EL, da Eira M, Lopes MI, Netto EM, Santini-Oliveira M, Leite OH, Machado AA, Tupinambas U, de Andrade Neto JL, Lima MP, Pedro Rde J, Miranda AF, Lewi DS, Santos BR, Portsmouth S, Wajsbrot DB, Cassoli LM. Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study. AIDS Res Hum Retroviruses. 2013 Sep;29(9):1203-10. doi: 10.1089/AID.2012.0330. Epub 2013 Jun 25. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 638 participants were screened, out of which 429 participants were screen failures and 209 were assigned to the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc | Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc | Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care. |
| 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 | Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death. | The safety analysis set composed of all participants who received at least one dose of study medication. | Posted | Number | Participants | Baseline to 30 days post-week 96 or early termination (ET) |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Maraviroc | Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
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|
| Baseline to 30 days post-week 96 or ET |
| Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
| Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Below limit of quantification was defined as less than 400 copies/milliliter (mL) | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
| Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
| Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
| Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
| Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
| Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status | Virus tropism was done by the Monogram Biosciences Trofile assay. | Time of virologic failure (VF) and Week 96 or EOT |
| Time to Virologic Failure (VF) | Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification. | Baseline to Week 96 or EOT |
| Number of Participants With Genotype Resistance | Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI). | Baseline through Week 96 |
| Brasília |
| Federal District |
| 70351-580 |
| Brazil |
| Pfizer Investigational Site | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Pfizer Investigational Site | Curitiba | Paraná | 80240-280 | Brazil |
| Pfizer Investigational Site | Nova Iguaçu | Rio de Janeiro | 26030-380 | Brazil |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90110-270 | Brazil |
| Pfizer Investigational Site | Florianópolis | Santa Catarina | 88025-301 | Brazil |
| Pfizer Investigational Site | Campinas | São Paulo | 13059-900 | Brazil |
| Pfizer Investigational Site | Campinas | São Paulo | 13083-887 | Brazil |
| Pfizer Investigational Site | Ribeirão Preto | São Paulo | 14048900 | Brazil |
| Pfizer Investigational Site | Santo André | São Paulo | 09060-650 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01246-900 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01307-001 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04040-002 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04121-000 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04231-030 | Brazil |
| Withdrawal by Subject |
|
| Other |
|
| Adverse Event |
|
| Randomized, not treated |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
|
|
| Primary | Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities | Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death. | The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. | Posted | Number | Participants | Baseline to 30 days post-week 96 or ET |
|
|
|
| Primary | Number of Participants With Treatment Emergent Malignancies | The safety analysis set composed of all participants who received at least one dose of study medication. | Posted | Number | Participants | Baseline to 30 days post-week 96 or ET |
|
|
|
| Primary | Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections | Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System. | The safety analysis set composed of all participants who received at least one dose of study medication. | Posted | Number | Participants | Baseline to 30 days post-week 96 or ET |
|
|
|
| Primary | Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality. | The safety analysis set composed of all participants who received at least one dose of study medication. | Posted | Number | Participants | Baseline to 30 days post-week 96 or ET |
|
|
|
| Secondary | Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) | The full analysis set (FAS) included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Last Observation Carried Forward (LOCF) method was used. | Posted | Number | Percentage of participants | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT) |
|
|
|
| Secondary | Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA | The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF. | Posted | Number | Percentage of participants | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
|
|
|
| Secondary | Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification | Below limit of quantification was defined as less than 400 copies/milliliter (mL) | The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF. | Posted | Number | Percentage of participants | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
|
|
|
| Secondary | Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | The FAS population included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF. | Posted | Mean | Standard Deviation | cells per microliter (cells/µL) | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
|
|
|
| Secondary | Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF. | Posted | Mean | Standard Deviation | cells/µL | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
|
|
|
| Secondary | Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF. | Posted | Mean | Standard Deviation | Percent CD4 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
|
|
|
| Secondary | Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. Missing data was imputed using LOCF. | Posted | Mean | Standard Deviation | Percent CD8 | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
|
|
|
| Secondary | Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status | Virus tropism was done by the Monogram Biosciences Trofile assay. | The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively. | Posted | Number | Participants | Time of virologic failure (VF) and Week 96 or EOT |
|
|
|
| Other Pre-specified | Change From Baseline in Human Immunodeficiency Virus (HIV) -1 Viral Load (Ribonucleic Acid [RNA]) at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT | Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/ml]). | The FAS included all participants who had taken at least one dose of study drug and provided any post-baseline efficacy evaluation. The 'n' signifies those participants who received study drug and were evaluated for this measure at time point for each group respectively. Missing data was imputed using LOCF. | Posted | Mean | Standard Deviation | log 10 copies/ml | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT |
|
|
|
| Other Pre-specified | Time to Virologic Failure (VF) | Virologic failure was defined as failing to achieve a reduction in HIV-1 RNA of at least 0.5 log10 copies/ml from baseline by the second viral load determination; or experiencing at least 0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from baseline more than 0.5 log10 copies/ml; or experiencing an HIV-1 RNA more than 1000 copies/ml after having achieved an HIV-1 RNA below level of quantification. | The FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. | Posted | Median | 95% Confidence Interval | Days | Baseline to Week 96 or EOT |
|
|
|
| Other Pre-specified | Number of Participants With Genotype Resistance | Evolution in resistance to OBT was shown by emergence of new primary or secondary resistance mutations to nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI). | FAS included all the participants who had taken at least one dose of the study drug and provided any post-baseline efficacy evaluation. Here, the 'N = 167' is signifying those participants who were evaluable for this measure at the specified time point for this arm group. | Posted | Number | Participants | Baseline through Week 96 |
|
|
|
| 34 |
| 206 |
| 185 |
| 206 |
| Febrile 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 |
|
| Bradycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Fat tissue increased | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cerebral toxoplasmosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Disseminated cryptococcosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Keratitis herpetic | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Meningitis meningococcal | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Intestinal T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Neoplasm of appendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Pseudomyxoma peritonei | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Urethral papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Leukoencephalopathy | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Monoplegia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bradyphrenia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Victim of homicide | Social circumstances | MedDRA 13.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lymphadenopathy | 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 |
|
| Arrhythmia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cleft lip | Congenital, familial and genetic disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Congenital optic nerve anomaly | Congenital, familial and genetic disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Porphyria non-acute | Congenital, familial and genetic disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ear disorder | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Eye disorder | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ocular icterus | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Aerophagia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Breath odour | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dental necrosis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Leukoplakia oral | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rectal discharge | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Administration site pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Application site nodule | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Crepitations | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Injection site nodule | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nodule | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ulcer | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Xerosis | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Anogenital warts | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthropod infestation | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Bacterial diarrhoea | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Bronchitis bacterial | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cerebral toxoplasmosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Dental fistula | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Dermatophytosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Gastrointestinal candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| HIV infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Herpes simplex ophthalmic | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Lymphogranuloma venereum | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Necrotising herpetic retinopathy | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Papilloma viral infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Secondary syphilis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Sinusitis bacterial | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Syphilis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tonsillitis bacterial | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Vulvovaginitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood testosterone decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Breath sounds abnormal | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
|
| Decreased appetite | 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 |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypovitaminosis | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Osteoporosis | 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 |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Benign renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Enchondromatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Fibrous histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Oral papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Carotid artery occlusion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Sleep phase rhythm disturbance | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Adjustment disorder with depressed mood | Psychiatric 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 |
|
| Disorientation | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Impatience | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Libido increased | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Albuminuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nephropathy | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Breast cyst | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Breast enlargement | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Genital lesion | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haematospermia | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Vaginal lesion | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Tonsillar disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Androgenetic alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Chloasma | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Eosinophilic pustular folliculitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Facial wasting | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lipodystrophy acquired | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Mass excision | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
|
| Varicose vein operation | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hyperaemia | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Grade 3: Alkaline phosphatase |
|
| Grade 3: Gamma-glutamyl transpeptidase (GGT) |
|
| Grade 3: Hyperbilirubinemia |
|
| Grade 3: Hyperuricemia |
|
| Grade 3: Lipase (n= 101) |
|
| Grade 3: Platelets |
|
| Grade 3: Potassium (Hyperkalemia) |
|
| Grade 3: Serum amylase |
|
| Grade 4: Alanine aminotransferase (ALT) |
|
| Grade 4: Aspartate aminotransferase (AST) |
|
| Grade 4: Absolute neutrophil count (ANC) |
|
| Grade 4: Alkaline phosphatase |
|
| Grade 4: Gamma-glutamyl transpeptidase (GGT) |
|
| Grade 4: Hyperbilirubinemia |
|
| Grade 4: Hyperuricemia |
|
| Grade 4: Lipase (n= 101) |
|
| Grade 4: Platelets |
|
| Grade 4: Potassium (Hyperkalemia) |
|
| Grade 4: Serum amylase |
|
| Measurements |
|---|
|
| Neoplasm of appendix |
|
| Title | Measurements |
|---|---|
|
| Pneumocystis jiroveci pneumonia |
|
| Leukoencephalopathy |
|
| Title | Measurements |
|---|---|
|
| White blood cell count (>1.5*ULN) |
|
| Absolute lymphocytes (<0.8*LLN) |
|
| Absolute lymphocytes (>1.2*ULN) |
|
| Percent lymphocytes (<0.8*LLN) (n= 1) |
|
| Percent lymphocytes (>1.2*ULN) (n= 1) |
|
| Percent neutrophils (<0.8*LLN) (n= 1) |
|
| Percent neutrophils (>1.2*ULN) (n= 1) |
|
| Absolute basophils (>1.2*ULN) |
|
| Percent basophils (>1.2*ULN) (n= 1) |
|
| Absolute eosinophils (>1.2*ULN) |
|
| Percent eosinophils (>1.2*ULN) (n= 1) |
|
| Absolute monocytes (>1.2*ULN) |
|
| Percent monocytes (>1.2*ULN) (n= 1) |
|
| Direct Bilirubin (>1.5*ULN) |
|
| Indirect bilirubin (>1.5*ULN) |
|
| Lactose dehydrogenase (LDH) (>3.0*ULN) |
|
| Total protein (<0.8*LLN) |
|
| Total protein (>1.2*ULN) |
|
| Albumin (<0.8*LLN) |
|
| Albumin (>1.2*ULN) |
|
| Blood urea nitrogen (BUN) (>1.3*ULN) |
|
| Cholesterol (>1.3*ULN) |
|
| High density lipoprotein cholesterol (<0.8*LLN) |
|
| Low density lipoprotein cholesterol (>1.2*ULN) |
|
| Triglycerides (>1.3*ULN) |
|
| Calcium (<0.9*LLN) |
|
| Calcium (>1.1*ULN) |
|
| Creatine kinase (CK) (>2.0*ULN) |
|
| Title | Measurements |
|---|---|
|
| Week 24 (n= 185) |
|
| Week 36 (n= 171) |
|
| Week 48 (n= 158) |
|
| Week 60 (n= 141) |
|
| Week 72 (n= 137) |
|
| Week 84 (n= 125) |
|
| Week 96 or EOT (n= 109) |
|
| LOCF (n= 206) |
|
| Title | Measurements |
|---|---|
|
| Week 24 (n= 185) |
|
| Week 36 (n= 171) |
|
| Week 48 (n= 158) |
|
| Week 60 (n= 141) |
|
| Week 72 (n= 137) |
|
| Week 84 (n= 125) |
|
| Week 96 or EOT (n= 109) |
|
| LOCF (n= 206) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n= 190) |
|
| Week 24 (n= 185) |
|
| Week 36 (n= 171) |
|
| Week 48 (n= 158) |
|
| Week 60 (n= 141) |
|
| Week 72 (n= 137) |
|
| Week 84 (n= 125) |
|
| Week 96 or EOT (n= 109) |
|
| LOCF (n= 206) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 12 (n= 186) |
|
| Change at Week 24 (n= 184) |
|
| Change at Week 36 (n= 165) |
|
| Change at Week 48 (n= 154) |
|
| Change at Week 60 (n= 134) |
|
| Change at Week 72 (n= 129) |
|
| Change at Week 84 (n= 124) |
|
| Change at Week 96 or EOT (n= 107) |
|
| Change at LOCF (n= 201) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 12 (n= 186) |
|
| Change at Week 24 (n= 185) |
|
| Change at Week 36 (n= 165) |
|
| Change at Week 48 (n= 155) |
|
| Change at Week 60 (n= 135) |
|
| Change at Week 72 (n= 130) |
|
| Change at Week 84 (n= 124) |
|
| Change at Week 96 or EOT (n= 107) |
|
| Change at LOCF (n= 201) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 12 (n= 186) |
|
| Change at Week 24 (n= 184) |
|
| Change at Week 36 (n= 165) |
|
| Change at Week 48 (n= 154) |
|
| Change at Week 60 (n= 134) |
|
| Change at Week 72 (n= 129) |
|
| Change at Week 84 (n= 124) |
|
| Change at Week 96 or EOT (n= 107) |
|
| Change at LOCF (n= 201) |
|
| Title | Measurements |
|---|---|
|
| Change at Week 12 (n= 186) |
|
| Change at Week 24 (n= 185) |
|
| Change at Week 36 (n= 165) |
|
| Change at Week 48 (n= 155) |
|
| Change at Week 60 (n= 135) |
|
| Change at Week 72 (n= 130) |
|
| Change at Week 84 (n= 124) |
|
| Change at Week 96 or EOT (n= 107) |
|
| Change at LOCF (n= 201) |
|
| Title | Measurements |
|---|---|
|
| Change at week 12 (n= 190) |
|
| Change at week 24 (n= 185) |
|
| Change at week 36 (n= 171) |
|
| Change at week 48 (n= 158) |
|
| Change at week 60 (n= 141) |
|
| Change at week 72 (n= 137) |
|
| Change at week 84 (n= 125) |
|
| Change at week 96 or EOT (n= 109) |
|
| Change at LOCF (n= 206) |
|
| Title | Measurements |
|---|
|
| VF: NRTI and NNRTI |
|
| VF: NRTI and PI |
|
| VF: NNRTI and PI |
|
| VF: NRTI and NNRTI and PI |
|
| VF: no NRTI, no NNRTI and no PI |
|
| VF: no test result data |
|